MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - VERSION RO D; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5901-1103
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "the surgeon was broaching the humerus with the broach handle and version rod screwed into the broach.As the surgeon was backing the broach out, he hit the alignment rod and it snapped leaving a piece of the thread stuck inside the 30° slot.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The event details states clearly that : "as the surgeon was backing the broach out, he hit the alignment rod and it snapped ".According to this statement, the user hit the device.The op tech clearly states that the device is not a weight bearing device: " the version rod is not intended to be a load bearing instrument.A review of the device history was not possible because the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the surgeon was broaching the humerus with the broach handle and version rod screwed into the broach.As the surgeon was backing the broach out, he hit the alignment rod and it snapped leaving a piece of the thread stuck inside the 30° slot.".

• Brand Name: REUNION TSA - VERSION RO D
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11241266
• Report Number: 0008031020-2021-00032
• Device Sequence Number: 3927837
• Product Code: LXH
• UDI-Device Identifier: 07613327099409
• UDI-Public: 07613327099409
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 03/12/2021

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: 5901-1103
• Device Catalogue Number: 5901-1103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1