MAUDE Adverse Event Report: STRYKER GMBH MODUL 4.0 MM; SCREW, FIXATION, BONE

Catalog Number	940184
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that modul 4.0 mm was alleged of ' device damaged' could be confirmed.Based on investigation, the root cause was attributed to be other related.The failure was caused due to possible inadequate unpacking prior to kit building.Unfortunately no further information could be obtained.The device inspection revealed the following: it is clearly visible that one edge of the returned module has indeed two swarf indentions.As reported; the swarf caused a blood drawing scratch on the operative's lh thumb.Note that our manufacturing plant has tried to reconstruct the occurred damage here the result: we tried to reconstruct the occurred damage with a standard carpet knife (stanley knife) which we use for our unpackaging processes for supplied tray articles.It is the only tool in our manufacturing facility we could think of that would be capable to damage an article like the shown example.We can prove (done several tests) that it is possible to create this error pattern with the carpet knife but only with a new blade we were able to create a sliver / swarf like that.Also looking at the electropolishing process of our supplier, they unpack by hand and use the same packaging material again for the return.So no knifes are involved at their process either.Note that the this affected lot has not been unpacked during our standard process and was neither part of a standard rework that included a repackaging.In conclusion it is not likely that this damage occurred during any step of the stryker manufacturing process for lot k0a119c.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.
Event or Problem Description
The stryker kit build operative reported that the drill tray, part # 940184 lot # k0a119c, has an almost invisible, very sharp, piece of swarf.The swarf caused a blood drawing scratch on the operative's lh thumb.It requires no medical treatment.

• Brand Name: MODUL 4.0 MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8162191
• Report Number: 0008031020-2018-01054
• Device Sequence Number: 2879773
• Product Code: HWC
• UDI-Device Identifier: 07613327088250
• UDI-Public: 07613327088250
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K133451
• 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): 12/13/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 940184
• Device Lot Number: K0A119C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/13/2018
• 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