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

Model Number	62-32440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that during the procedure, the repositioning pin broke off and a piece still remains in the patient.
Event or Problem Description
It was reported that during the procedure, the repositioning pin broke off and a piece still remains in the patient.
Additional Manufacturer Narrative
The device was returned for evaluation and the investigation shows that the product subject to the complaint had reached its life time at the event date of the reported incident.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.

• 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; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 16997221
• Report Number: 0008010177-2023-00032
• Device Sequence Number: 14316443
• Product Code: HTW
• UDI-Device Identifier: 07613153171096
• UDI-Public: 07613153171096
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/02/2023

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
• Device Model Number: 62-32440
• Device Catalogue Number: 62-32440
• Device Lot Number: Z1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2009
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown