MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 40MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 5572-4540

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "the patient returned to dr.'s office for a follow-up.Upon examining x-rays it was obvious that peripheral screws had migrated through the baseplate requiring revision surgery.".

Event Description

As reported: "the patient returned to dr.'s office for a follow-up.Upon examining x-rays it was obvious that peripheral screws had migrated through the baseplate requiring revision surgery.".

Manufacturer Narrative

Correction: please refer to section d9/h3, the device remains in the patient.The reported event could be confirmed, based on the x-rays provided.The visual inspection of the other returned devices showed that : the baseplate shows some deformation on the lips that bite into the screws at the level of the peripheral holes.The returned peripheral screw and central screw do not show any locking thread deformation.A dimensional inspection was performed, and the peripheral screw holes were measured and were found to be larger than in the drawing.The screw holes also show a deformation of the material on the lip that bites into the screw.As a summary, the peripheral screw holes of the baseplate were badly enlarged, probably during the drilling phase of the operation.The diameter of the lip that holds into the screw should be 0.209 inches according to the drawing, but was found to be between 0.233 inches and 0.2373 inches.This deformation could easily explain the migration of the screws reported.The screws are not the root cause of the migration.Based on investigation, the root cause was attributed to the enlargement of the screw holes of the baseplate, most probably during the insertion of the screws.A review of the device history for the reported lot did not indicate any abnormalities.The size of the peripheral screw holes is checked at a rate of 100% with a go/no go pin during manufacturing.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 complaint report will be updated.H3 other text : device remains in the patient.

• Brand Name: 4.5MM PERIPHERAL SCREW - 40MM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11368881
• MDR Text Key: 233264878
• Report Number: 0008031020-2021-00046
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098778
• UDI-Public: 07613327098778
• Combination Product (y/n): N
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: 5572-4540
• Device Catalogue Number: 5572-4540
• Device Lot Number: XM63AX
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/03/2021
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 68