MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 105MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	33625105
Medical Device Problem Code	Fracture (1260)
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.
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 labeled for single use and usage of device.The reported event could be confirmed.Based on investigation, 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).The device inspection revealed the following: the returned lag screw is indeed badly damaged (both connecting pins (pegs) are completely broken off).It indicates that either the lag screw had not been properly assembled with the one-step insertion wrench or just inadequate use has resulted in these damages.The threaded front part is still in good condition though, which indicates that the user must have encountered difficulties with the correct assembly.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: STANDARD LAG SCREW OMEGA 105MM LENGTH
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8452788
• Report Number: 0008031020-2019-00312
• Device Sequence Number: 429772
• Product Code: KTT
• UDI-Device Identifier: 07613327092882
• UDI-Public: 07613327092882
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K955306
• 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: Health Professional
• Device Catalogue Number: 33625105
• Device Lot Number: L58912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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