MAUDE Adverse Event Report: STRYKER GMBH ONE-STEP INSERTION WRENCH OMEGA NON-MODULAR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	704047
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The 'teeth' at the base of the omega lag screw sheared off during insertion with the 'one piece lag screw inserter (- 704047), which was also damaged.This was identified during the procedure, and upon inspection post procedure, the issue was identified.
Additional Manufacturer Narrative
Correction: sections concomitant medical products and device evaluated by mfr.The reported event could not be confirmed, since the device was not returned.Note that only some pictures were made available, whereas some damages of this device are visible.Based on the given information and the visible damages of the lag screw, the root cause was attributed to be user related.The failure was caused by inadequate assembly or simply too much mechanical force was applied during lag screw insertion (possibly the connecting bolt may have not been place tighten enough and subsequently the pins of the one step insertion wrench were not in position anymore).Nevertheless more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.Unfortunately we have only received some pictures of the damaged one-step insertion wrench.The connecting pins (pegs) of the lag screw were still intact at the time when these pictures were taken, the wrench was already damaged at the very front though.Note that damaged instruments should be changed prior use.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The 'teeth' at the base of the omega lag screw sheared off during insertion with the 'one piece lag screw inserter (- 704047), which was also damaged.This was identified during the procedure, and upon inspection post procedure, the issue was identified.

• Brand Name: ONE-STEP INSERTION WRENCH OMEGA NON-MODULAR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8451269
• Report Number: 0008031020-2019-00311
• Device Sequence Number: 11484971
• Product Code: LXH
• UDI-Device Identifier: 07613154334988
• UDI-Public: 07613154334988
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 704047
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other