MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR OFFSET QUICK CONNECT INSERTER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	1020-1860
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Surgeon was using the modular offset stem inserter for the accolade ii stem, and when impacting the stem into the femoral canal, a small metal chip broke off.Surgeon removed chip and stem was successfully inserted.Modular offset stem inserter and chip have been acquired for analysis.
Event or Problem Description
Surgeon was using the modular offset stem inserter for the accolade ii stem, and when impacting the stem into the femoral canal, a small metal chip broke off.Surgeon removed chip and stem was successfully inserted.Modular offset stem inserter and chip have been acquired for anlaysis.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an accolade inserter was reported.The event was confirmed via provided photos.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photos present the reported device with blood on it and a small piece was fractured off it.The fractured piece appears to be from the shaft.The reported event is confirmed.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that a small metal chip broke off from the accolade inserter.This was confirmed via provided photos.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot details and return of the products are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MODULAR OFFSET QUICK CONNECT INSERTER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11437292
• Report Number: 0002249697-2021-00395
• Device Sequence Number: 17166830
• Product Code: LPH
• UDI-Device Identifier: 07613327252910
• UDI-Public: 07613327252910
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K153345
• 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): 05/13/2021

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: 1020-1860
• Device Catalogue Number: 1020-1860
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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: Other