MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG OBWEGESER RAMUS SPLITT OSTEOTOME, 12MM, 21.5CM; INSTRUMENT

Model Number 01-17871

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  malfunction  

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 distributor that the osteotomes chipped away intra-operatively.

Event Description

It was reported by the distributor that the osteotomes chipped away intra-operatively.

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.

• Brand Name: OBWEGESER RAMUS SPLITT OSTEOTOME, 12MM, 21.5CM
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 9565126
• MDR Text Key: 198595488
• Report Number: 0008010177-2020-00004
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 04546540142542
• UDI-Public: 04546540142542
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-17871
• Device Catalogue Number: 01-17871
• Device Lot Number: 1000029856
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1