MAUDE Adverse Event Report: STRYKER GMBH IMPACTOR ASSEMBLY OMEGA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	704001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that impactor assembly omega was alleged of issue ¿instrument - breakage during implantation¿ could be confirmed with the pictures provided.Device inspection revealed the following: the received picture depicts that the impactor assembly omega was snapped around the proximal region.The breakage has happened in the impactor head.This is a classic case of breakage when external excessive forces are applied, and this could be confirmed with the additional information provided by rep.That the impactor was used for around maybe 15 hits.The damaged part indicated towards high impact forces being applied on the impactor.Note that this is a device where consistent high forces are being applied due to which there are chances of breakage of the device.It cannot be excluded that normal material wear also contributed to the failure over the years of usage.Material inspection: the raw material certificates from the supplier were reviewed.They correspond to the material defined on the drawing and to the internal material specification.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is user related.The breakage of the impactor happened due to intense hammering during use and this could be confirmed with the additional information provided by rep.That the impactor was used for around maybe 15 hits.The op-tech instructs the user that: ¿note: use gentle hammering only ¿ otherwise the impactor may be destroyed.¿ if any additional information is provided, the investigation will be reassessed.Device discarded.
Event or Problem Description
As reported: "the end of the omega lag screw stripped on insertion and in the same case, the plate impactor snapped.Plate impactor snapped during use.No replacement was available, a bristow wedged in the notch was used in place." additionally reported: "a larger incision was needed.The procedure took longer to replace the lag screw.15min surgical delay.Improvisation was needed to seat the plate on the bone.A bristow wedged in the notch was used in place." "the larger incision was made due to the screw stripping first trying to ¿helicopter¿ the screw around using the plate and barrel.A larger incision was also needed because it was more difficult to seat the plate through the tissue without the impactor.".

• Brand Name: IMPACTOR ASSEMBLY OMEGA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10135894
• Report Number: 0008031020-2020-01563
• Device Sequence Number: 3184637
• Product Code: LXH
• UDI-Device Identifier: 04546540113078
• UDI-Public: 04546540113078
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 704001
• Device Catalogue Number: 704001
• Device Lot Number: 02519L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/09/2020
• 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
• Patient Age: 68 YR