MAUDE Adverse Event Report: STRYKER GMBH CONNECTING BOLT OMEGA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	704004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reports that the screw thread broke off from the product.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the threaded tips of both returned connecting bolts are indeed completely broken / snapped off.The broken surface of both connecting bolts are homogenous which again indicates conformity to the given specification.The surgeon possible encountered some difficulties as this happened to two devices.Some damages on the entire thread are clearly visible.These damages on the last two turns of the thread near the break point are severe, which indicates that the connecting bolts must have gotten loose and the applied force caused the cannulated threaded tips to break off.A review of the device history for the reported lot did not indicate any abnormalities.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inadequate assembly or 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 positioned anymore).If any further information is provided, the investigation report will be updated.
Event or Problem Description
The customer reports that the screw thread broke off from the product.

• Brand Name: CONNECTING BOLT OMEGA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9521809
• Report Number: 0008031020-2019-02372
• Device Sequence Number: 2851541
• Product Code: LXH
• UDI-Device Identifier: 07613153054436
• UDI-Public: 07613153054436
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: Health Professional
• Device Model Number: 704004
• Device Catalogue Number: 704004
• Device Lot Number: 06124L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1