SHOULDER INSTRUMENTS

Description of Event or Problem

ONE K-WIRE SEVERELY BENT, ONE K-WIRE SNAPPED AND ONE K-WIRE SLIGHTLY BENT DURING SURGERY. THE WIRE WAS USED AS NORMAL. THE WIRE WAS DRILLED INTO THE GLENOID AND SNAPPED IN THE PROCESS. IT COULD BE REMOVED WITH PLIERS. THE PATIENT SUFFERED NO HARM. ALL THREE WIRES HAD THE SAME BATCH NUMBER.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 8 JULY 2026 LOT 2611268: 75 ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2026. EXPIRATION DATE: 05-MAY-2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (b)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT FOR BREAKAGE DURING THE PERIOD OF REVIEW. SEMIFINISHED LOT: 64.10.0422 K-WIRE D 2.5 X 200MM - SF LOT. MAT82117: 2453 ITEMS WERE MANUFACTURED AND RELEASED 25-JUL-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2 SIMILAR REPORTED EVENTS FOR BREAKAGE AND NO SIMILAR REPORTED EVENT FOR DEFORMATION WERE RECEIVED DURING THE PERIOD OF REVIEW. ROOT CAUSE:ALTHOUGH IT CANNOT BE CONFIRMED, THE CONDITIONS OF SURGICAL VARIATION AND INTRAOPERATIVE FACTORS (E.G., BONE QUALITY, DRILLING ANGLE, BENDING/REDIRECTION, AXIAL OR TORSIONAL FORCES, SURGICAL HANDLING) LIKELY RESULTED IN THE APPLIED FORCES EXCEEDING THE INHERENT LIMITATIONS OF THE DEVICE RESISTANCE AS CONSTRAINED BY THE COLLECTIVE DESIGN INPUTS. THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.