MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, AO FITTING BIXCUT 8,0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	0225-6080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Customer reported to sales rep that: "breakage of a reamer during procedure" procedure ended by changing reamer." email from customer from 26-06-2020 : update ¿indeed i can confirm we have a reamer bixcut stryker diam 8 ref k0008f1 that broke during the surgery on (b)(6) 2020.".
Event or Problem Description
Customer reported to sales rep that: "breakage of a reamer during procedure" procedure ended by changing reamer".Email from customer from (b)(6) 2020 : update ¿indeed i can confirm we have a reamer bixcut stryker diam 8 ref k0008f1 that broke during the surgery on (b)(6) 2020.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure, although the reamer had been refurbished externally by a third party.The returned im reamer (lot# k0c08f1), although was found to be broken, had been refurbished as indicated by a third party engraving on the adapter.Thus, further inspection is deemed dispensable.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation it was found that although there was failure confirmation but there was already a refurbishment done to the reamer as indicated by the engraving on the adapter.This marking is not made by stryker at any point of time.Instruments which are refurbished by third parties/external sources and then returned to the customers are not regarded to have been put on the market by stryker.After any sort of rework done externally, they become products of a third party.There are no warranty claims against stryker for third-party products.If any additional information is provided, the investigation will be reassessed.

• Brand Name: IM REAMER, AO FITTING BIXCUT 8,0X480 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10278884
• Report Number: 0009610622-2020-00321
• Device Sequence Number: 1045323
• Product Code: LXH
• UDI-Device Identifier: 04546540145338
• UDI-Public: 04546540145338
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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 Model Number: 0225-6080
• Device Catalogue Number: 02256080
• Device Lot Number: K0C08F1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1