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 Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding crack/fracture involving a cutting edge handle was reported.The event was confirmed.Method & results: -device evaluation and results: the device was received by the supplier and their report noted, "there were signs of wear in the form of scratches, nicks and gouges throughout the complaint sample; there was material deformation observed on the power adaptor." [.] "the power adaptor coupling had fractured away from the straight reamer handle, however, the piece that had broken away was not received with the complaint sample." -medical records received and evaluation: not performed since no medical records were provided.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation confirmed the reported event based on the supplier's analysis which indicated the reported event is confirmed however, the cause is unknown.
Event or Problem Description
Surgeon was reaming the acetabular and base of quick release sheared on reamer.Update: no surgical delay nor any adverse events were reported as a result of this malfunction.

• 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: 7948878
• Report Number: 0002249697-2018-03249
• Device Sequence Number: 1513686
• Product Code: LPH
• UDI-Device Identifier: 07613327211825
• UDI-Public: 07613327211825
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: V10871003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 10/09/2018
• 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