MAUDE Adverse Event Report: STRYKER GMBH NITINOL PILOT WIRE REUNION; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5901-6072
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
During the reaming process of glenoid for a conversion of a total shoulder to a reverse.Upon removing the reamer handle from the glenoid the nitinol pilot wire was missing from the reamer shaft.An xray confirmed that the wire was lodged in the posterior aspect of the scapula with no sign of the end of wire from glenoid perspective.Doctor worked on trying to retrieve from the glenoid for sometime till an incision was made posterior scapula to retrieve.There was additional time added to the procedure.All in total between an 90-120 min.
Event or Problem Description
During the reaming process of glenoid for a conversion of a total shoulder to a reverse.Upon removing the reamer handle from the glenoid the nitinol pilot wire was missing from the reamer shaft.An xray confirmed that the wire was lodged in the posterior aspect of the scapula with no sign of the end of wire from glenoid perspective.Doctor worked on trying to retrieve from the glenoid for sometime till an incision was made posterior scapula to retrieve.There was additional time added to the procedure.All in total between an 90-120min.
Additional Manufacturer Narrative
The reported event that nitinol pilot wire reunion was alleged of 'instrument - breakage during implantation' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: NITINOL PILOT WIRE REUNION
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10237062
• Report Number: 0008031020-2020-01845
• Device Sequence Number: 11369137
• Product Code: KWS
• UDI-Device Identifier: 07613327293845
• UDI-Public: 07613327293845
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K172210
• 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): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 5901-6072
• Device Catalogue Number: 5901-6072
• Device Lot Number: B4G11-05L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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: Required Intervention
• Patient Age: 54 YR