MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - MODULAR RA TCHETING HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5901-1120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2019
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
During a shoulder revision procedure, it was discovered that the strike plate was missing from the device.The patient and o.R.Were inspected and the strike plate was not found.It is unknown if the strike plate went missing during the procedure, or prior to the procedure (prior procedure or spd).The surgeon elected to continue using the device, requiring additional mallet strikes.Surgery was completed successfully with an approximate 2 minute delay.
Additional Manufacturer Narrative
The reported event that could be confirmed.Based on investigation, the root cause was attributed to be normal wear and tear over the years.Given information: it is unknown if the strike plate went missing during the procedure, or prior to the procedure (prior procedure or spd).The device inspection revealed the following: the striking plate of the returned ratcheting handle is completely broken off (gone missing as reported).A close up (done by the microscope) shows inner damages, rust and deposits are evident as well which indicate that this is rather an old and often used instrument.Note that this returned instrument is not engraved with "do not disassemble" which indicates that the device was manufactured prior to 21/aug/2012, which is when that engraving was implemented.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
During a shoulder revision procedure, it was discovered that the strike plate was missing from the device.The patient and operating room were inspected and the strike plate was not found.It is unknown if the strike plate went missing during the procedure, or prior to the procedure (prior procedure or spd).The surgeon elected to continue using the device, requiring additional mallet strikes.Surgery was completed successfully with an approximate 2 minute delay.

• Brand Name: REUNION TSA - MODULAR RA TCHETING HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8941794
• Report Number: 0008031020-2019-01185
• Device Sequence Number: 2657842
• Product Code: LXH
• UDI-Device Identifier: 07613327099454
• UDI-Public: 07613327099454
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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 Catalogue Number: 5901-1120
• Device Lot Number: B5KFP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR