MAUDE Adverse Event Report: STRYKER TRAUMA KIEL REAMER SHAFT, MOD.TRINKLE BIXCUT Ø8.0X448 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02273000S
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Disposed of during the case.
Event or Problem Description
Sterile single use bixcut reamer shaft opened in theatre during gamma nail procedure & surgeon/scrub nurse has identified corrosion/rust on distal end of instrument.Replacement device opened & used.
Event or Problem Description
Sterile single use bixcut reamer shaft opened in theatre during gamma nail procedure & surgeon/scrub nurse has identified corrosion/rust on distal end of instrument.Replacement device opened & used.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.No deviation was found in the packaging & sterilization processes.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 given information a deficiency of the reamer could not be verified.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: REAMER SHAFT, MOD.TRINKLE BIXCUT Ø8.0X448 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8428412
• Report Number: 0009610622-2019-00109
• Device Sequence Number: 2887799
• Product Code: LXH
• UDI-Device Identifier: 04546540430199
• UDI-Public: 04546540430199
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 05/01/2019

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 Expiration Date: 08/31/2023
• Device Catalogue Number: 02273000S
• Device Lot Number: K0EA3FD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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
• Patient Age: 85 YR