MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 16MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5572-4516
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Post-market clinical evaluation of the reunion reverse shoulder arthroplasty (rsa) system: subject (b)(6).Description of the event: acromial stress reaction.Actions taken: sling for two weeks.Resolved with sequelae: (b)(6) 2021.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : clinical case - still in patient.
Additional Manufacturer Narrative
The received x-rays were reviewed by medical affairs and the event of the acromial stress reaction could not be conclusively confirmed.A device inspection was not possible since the affected device was not returned.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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.The available information was forwarded to medical affairs for review with following feedback: "the 6 months axial x-ray possibly confirms an acromial stress reaction, although the images are not fully comparable from the angle they were taken.It shows some condensation of bone (little bit whiter on the x-ray) which together with clinical information most likely has led to this conclusion.I do not find the difference very convincing.Typically, in doubtful cases a nuclear scintigraphy (bone scan) would provide the answer to this clinical question.Therefore in this case i can neither confirm, nor deny this conclusion of the investigator." 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Post-market clinical evaluation of the reunion reverse shoulder arthroplasty (rsa) system: subject 02-067.Description of the event: acromial stress reaction.Actions taken: sling for two weeks resolved with sequelae: (b)(6) 2021.

• Brand Name: 4.5MM PERIPHERAL SCREW - 16MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 17255700
• Report Number: 0008031020-2023-00271
• Device Sequence Number: 20304632
• Product Code: KWS
• UDI-Device Identifier: 07613327098716
• UDI-Public: 07613327098716
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 5572-4516
• Device Catalogue Number: 5572-4516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 82 YR
• Patient Sex: Female
• Patient Weight: 66 KG