MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACETABULAR REAMER HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	2102-0410
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2018
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 one other event for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Reamer shaft handle broke under usage.Replacement handle was used.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a cutting edge handle was reported.The event was confirmed.Conclusions: the investigation confirmed the reported event based on the supplier's analysis which indicated the reported event is confirmed and attributed to wear.
Event or Problem Description
Reamer shaft handle broke under usage.Replacement handle was used.

• Brand Name: ACETABULAR REAMER HANDLE
• 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: 7910385
• Report Number: 0002249697-2018-03052
• Device Sequence Number: 1936633
• Product Code: LPH
• UDI-Device Identifier: 07613327211825
• UDI-Public: 07613327211825
• Combination Product (Y/N): N
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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 Catalogue Number: 2102-0410
• Device Lot Number: V2009235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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