inforMED
MalfunctionLRY

KERRISON BLK COATED 130 UP 180X1MM THIN

Received Jan 26, 2016

Report 2916714-2016-00044 · MDR key 5391058

Device

Generic name

Bone Punches

Manufacturer

Aesculap Ag

Model number

FK906R

Catalog number

FK906R

Lot number

52048747

Product problems

  • Break
  • Break

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 MANUFACTURING SITE EVALUATION: ON-GOING

Description of Event or Problem

COUNTRY OF COMPLAINT: PORTUGAL. BROKEN FOOT PLATE. (B)(4).

Additional Manufacturer Narrative

CORRECTION: SEE SECTION B5 FOR RELATED MED WATCH REPORTS CORRECTION: AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018

Description of Event or Problem

MULTIPLE MEDWATCH REPORTS BEING FILED THAT ARE RELATED/SIMILAR TO THIS EVENT, PLEASE SEE: 2916714-2016-00043, 2916714-2016-00044, 2916714-2016-00045, 2916714-2016-00046, 2916714-2016-00047, 2916714-2016-00048.