MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1320-0111

Device Problem Failure to Align (2522)

Patient Problem No Information (3190)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The customer reported two failed gamma nails where the use of the stryker jig may be a factor.The customer has multiple sets and is unable to identify which jig is potentially at issue.They are returning 5 jigs for inspection under this pi.

Manufacturer Narrative

The reported event was not confirmed ¿ since no product or other evidences were available.Review of complaint history, labelling and capa databases could not be performed since no lot.No was communicated.The risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).More detailed information about the complaint event, e.G.Results of surgeon¿s pre-operative tests, must be available in order to determine the root cause of the complaint event.Pre-operative functional testing is required in the labelling.Potential misalignment of products, causing mis drilling with damage of implants, can easily be detected during required functional check prior to use.With available information root cause for alleged mis drilling could not be determined.In case the instrument and / or other essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.Device disposition unknown.

Event Description

The customer reported two failed gamma nails where the use of the stryker jig may be a factor.The customer has multiple sets and is unable to identify which jig is potentially at issue.They are returning 5 jigs for inspection under this pi.

• Brand Name: TARGET DEVICE GAMMA3
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 10101252
• MDR Text Key: 195105552
• Report Number: 0009610622-2020-00269
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (y/n): N
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1320-0111
• Device Catalogue Number: 13200111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1