MAUDE Adverse Event Report: STRYKER GMBH 6.5MM CENTER SCREW - 44M M; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	5573-6544
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a broken screw inside the glenoid.Surgeon had to leave the broken central screw, as they were unable to retrieve it.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that there was a broken screw inside the glenoid.Surgeon had to leave the broken central screw, as they were unable to retrieve it.
Additional Manufacturer Narrative
Correction: d9 product available to stryker.The reported event was not confirmed since the device was not returned for evaluation and no additional information was provided.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.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If any further information is provided or the device is returned, the complaint report will be updated.

• Brand Name: 6.5MM CENTER SCREW - 44M M
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19924381
• Report Number: 0008031020-2024-00301
• Device Sequence Number: 8141040
• Product Code: HSD
• UDI-Device Identifier: 07613327098860
• UDI-Public: 07613327098860
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• 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): 10/03/2024

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: Lay User/Patient
• Device Expiration Date: 02/01/2025
• Device Catalogue Number: 5573-6544
• Device Lot Number: D81NYD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male