MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM

Catalog Number	62-32440
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that the instrument broke when the surgeon was attempting to reduce the fracture.The tip of the bone repositioning instrument remains in the patient, even though the surgeon did attempt to remove it for approximately one hour.Otherwise, it was reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The investigation shows that the product subject to the complaint had reached its life time at the event date of the reported incident.The relevant quality documents indicate that the product was manufactured according to specifications and was accepted into stock without any discrepancies.There is no indication for a quality issue with the article in question, nor is there any indication for a deviation from the defined quality specifications within development or manufacturing.No indications for unusual or unexpected circumstances could be identified, either.Moreover it is to be concluded that the reported incident originated from a common case of wear and tear resulting from aging as it is to be expected with mechanical medical devices subject to reprocessing after reaching their life time, not making any further action necessary.This complaint will be considered in statistical analyses at frequent intervals.
Event or Problem Description
It was reported that the instrument broke when the surgeon was attempting to reduce the fracture.The tip of the bone repositioning instrument remains in the patient, even though the surgeon did attempt to remove it for approximately one hour.Otherwise, it was reported that the procedure was completed successfully.

• Brand Name: UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8947234
• Report Number: 0008010177-2019-00058
• Device Sequence Number: 2510320
• Product Code: HTW
• UDI-Device Identifier: 07613153171096
• UDI-Public: 07613153171096
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 11/08/2019

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 Catalogue Number: 62-32440
• Device Lot Number: AB03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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