MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 LONG NAIL IMPLANT

Catalog Number UNK_KIE

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

Patient Problem No Code Available (3191)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device not available.

Event Description

The customer reported an extraction hook was broken. The instrument has been raised under pi (b)(4). The report stated that it broke during a revision case. This pi is open to reflect that revision. The surgery was to remove a broken right side gamma3 long nail which was implanted approximately 2yrs ago at the (b)(6) by another surgeon, and replaced with an omega dhs. The nail had broken at the point where the lag screw crosses through and there was mal-union of the initial fracture site. The lag screw, 5mm distal locking screw and proximal part of the nail were extracted. The distal portion of the nail remains in situ.

• Brand Name: UNKNOWN GAMMA3 LONG NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7301191
• MDR Text Key: 101118202
• Report Number: 0009610622-2018-00057
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/27/2018 Patient Sequence Number: 1