MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T7, 2.7X26MM; PLATE, FIXATION, BONE

Catalog Number	53-27226S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2019
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
In in-coming inspection at distribution, it was found that there was a foreign material (hair) in package.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the reported failure mode.Visual inspection: the part showed a hair under the printed label.Functional inspection: due to the nature of the complaint, a functional inspection was not considered necessary.Dimensional inspection: due to the nature of the complaint, a dimensional inspection was not considered necessary.Based on investigation, the root cause was attributed to be manufacturing related.No indications of material, 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
In in-coming inspection at distribution, it was found that there was a foreign material (hair) in package.

• Brand Name: BONE SCREW, T7, 2.7X26MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8804975
• Report Number: 0008031020-2019-00904
• Device Sequence Number: 320108
• Product Code: HRS
• UDI-Device Identifier: 04546540593931
• UDI-Public: 04546540593931
• Combination Product (Y/N): N
• PMA/510(K) Number: K080667
• 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): 09/18/2019

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: No Information
• Device Catalogue Number: 53-27226S
• Device Lot Number: 1000254395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1