MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL IMPLANT

Catalog Number UNK_KIE

Device Problem Malposition of Device (2616)

Patient Problems Perforation (2001); Hip Fracture (2349)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"the stryker sales representative reported that a patient who had been implanted with a gamma nail and a lag screw was revised. It was noticed post operatively that the nail was fine, but the lag screw had perforated the femoral head and migrated towards the pelvis. The healing process had finished when the lag screw went into the bone. There was no damage to arteries. The stryker sales representative noticed bony in growth between the explanted lag and set screws. The sales representative tried to remove the set screw from the explanted nail after the case but it had threaded onto the nail and was stuck".

• Brand Name: UNKNOWN GAMMA NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11680452
• MDR Text Key: 245848142
• Report Number: 0009610622-2021-00443
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/10/2021
• 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: 04/16/2021 Patient Sequence Number: 1