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

Model Number 62-32440

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  Injury  

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 Description

It was reported by the company representative that during the procedure, part of the instrument broke off.The tip of the bone repositioning instrument remains in the patient and after surgeon discretion, they opted to leave it.There are no further details at this time.

Event Description

It was reported by the company representative, that during the procedure.Part of the instrument broke off.The tip of the bone repositioning instrument remains in the patient.And after surgeon discretion, they opted to leave it.There are no further details at this time.

Manufacturer Narrative

The device has been received at the manufacturer for testing.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.

• Brand Name: UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10683327
• MDR Text Key: 211460678
• Report Number: 0008010177-2020-00054
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07613153171096
• UDI-Public: 07613153171096
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 62-32440
• Device Catalogue Number: 62-32440
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention