MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - EXTRAMEDUL LARY RESECTION GUIDE ASS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5901-1111
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	02/17/2020
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
It was reported that during a right reverse shoulder, the pin got stuck in the resection guide, and the pin connector snapped off of the guide.Rep was not present for the procedure and does not know how the issue was resolved, but is able to confirm the case was completed successfully.
Additional Manufacturer Narrative
Due to the current covid-19 pandemic it was not possible to inspect the product as the access to the facility is restricted.The investigation will be reassessed as soon as restriction is lifted.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 any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that during a right reverse shoulder, the pin got stuck in the resection guide, and the pin connector snapped off of the guide.Rep was not present for the procedure and does not know how the issue was resolved, but is able to confirm the case was completed successfully.
Additional Manufacturer Narrative
The reported event that a reunion tsa - extramedullary resection guide was alleged of 'instrument - assembling / disassembling impaired during implantation' could not be confirmed, since the device was returned and is perfectly functional.The device does not show any extensive signs of use.The different parts can perfectly be attached to each other in all dispositions.A review of the device history for the reported lot did not indicate any abnormalities.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
It was reported that during a right reverse shoulder, the pin got stuck in the resection guide, and the pin connector snapped off of the guide.Rep was not present for the procedure and does not know how the issue was resolved, but is able to confirm the case was completed successfully.

• Brand Name: REUNION TSA - EXTRAMEDUL LARY RESECTION GUIDE ASS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9832915
• Report Number: 0008031020-2020-00715
• Device Sequence Number: 726995
• Product Code: LXH
• UDI-Device Identifier: 07613327099447
• UDI-Public: 07613327099447
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 07/27/2020

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: 5901-1111
• Device Catalogue Number: 5901-1111
• Device Lot Number: 0063495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 04/28/2020; 07/01/2020
• Initial Report FDA Received Date: 03/14/2020
• Supplement Report FDA Received Date: 05/21/2020; 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR