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

Catalog Number	704004
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
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
It was reported that during insertion of the lag-screw using the one-step technique, and prior to fully seating the lag screw, the connecting bolt sheared off.During continued attempts to fully seat the screw, the lag screw interlocking tabs sheared off.Subsequent attempts to fully seat or remove the lag screw were difficult.It was reported that additional operative time was 30 minutes.
Event or Problem Description
It was reported that during insertion of the lag-screw using the one-step technique, and prior to fully seating the lag screw, the connecting bolt sheared off.During continued attempts to fully seat the screw, the lag screw interlocking tabs sheared off.Subsequent attempts to fully seat or remove the lag screw were difficult.It was reported that additional operative time was 30 minutes.
Additional Manufacturer Narrative
The reported event that connecting bolt omega was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to a user related issue.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 positioned anymore).The device inspection revealed the following: the threaded tip of the returned connecting bolt is indeed completely broken / snapped off (still stuck in the lag screw).The surface of the breakage (connecting bolt) is homogenous which again indicates conformity to the given specification.The returned lag screw is indeed badly deformed / damaged.It indicates that either the lag screw had not been properly assembled with the one step insertion wrench (whereas both connecting pins are also deformed) or just inadequate use has resulted in these deformations.These damages clearly indicate that the user must have encountered some difficulties during the lag screw insertion which resulted in these damages.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.If any further information is provided, the investigation report will be updated.

• 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: 7712311
• Report Number: 0008031020-2018-00519
• Device Sequence Number: 1065774
• Product Code: LXH
• UDI-Device Identifier: 07613153054436
• UDI-Public: 07613153054436
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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 Catalogue Number: 704004
• Device Lot Number: U14614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/04/2018
• 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