MAUDE Adverse Event Report: STRYKER GMBH STANDARD BARREL HIP PLATE, KEYED OMEGA 3 135°, 4 HOLES; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	597024S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a foreign body in an omega implant box.
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported a foreign body in an omega implant box.
Additional Manufacturer Narrative
The reported event could not be confirmed since the original packaging was not returned and since the complete packaging is not visible on the received pictures.The device inspection revealed the following: a steel ball with a diameter of 1.98mm was returned for evaluation.The ball has no markings or any other identifying features on it.The original package and the implant were not returned for evaluation.The received picture also don't show the complete original package, there is just a section of an opened blister pack with the returned ball inside visible.The identification of the catalog- and lot number was made based on a patient label sticker on a implant sheet.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.Based on the available information the root cause of this occurrence cannot be defined and without the original package it is not possible to confirm the event.As part of the complaint evaluation the complete manufacturing process of the device was reviewed.In none of the performed process steps is a steel ball with a similar dimension used.Also the areas with balls, that could get in contact with the product, of the involved machines were reviewed.It was found that none of these balls is missing and that these balls do not have the same diameter like the returned one.These findings speak against a contamination with the ball during the manufacturing and packaging process.If more information is provided, the case will be reassessed.

• Brand Name: STANDARD BARREL HIP PLATE, KEYED OMEGA 3 135°, 4 HOLES
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13524633
• Report Number: 0008031020-2022-00054
• Device Sequence Number: 14801720
• Product Code: KTT
• UDI-Device Identifier: 07613154325085
• UDI-Public: 07613154325085
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K062066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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 Expiration Date: 07/31/2026
• Device Model Number: 597024S
• Device Catalogue Number: 597024S
• Device Lot Number: H48947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown