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 Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate the products were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that the trident reamer handle will not clip down to attach to the reamers.The case was completed using competitor reamers with a 5 minute delay to surgery.
Additional Manufacturer Narrative
An event regarding assembly issue involving an acetabular reamer handle was reported.The event was not confirmed.The returned device is a source controlled device; evaluation was performed by the supplier, greatbatch medical.The supplier indicated, "a reamer attachment simulator was used to check the reamer attachment coupling.No issues were observed.A power adaptor simulator was used to check connection with the power adaptor.No issues were observed.The complaint sample appeared to be brand new and showed little to no signs of use.The returned device was etched per applicable drawings." medical records received and evaluation: not performed since no patient involvement was reported.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies there has been no other event for the lot referenced.The investigation could not be confirmed as no failure was detected on the complaint sample.See supplier investigation results attached for further information on the supplier¿s assessment.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The customer reported that the trident reamer handle will not clip down to attach to the reamers.The case was completed using competitor reamers with a 5 minute delay to surgery.

• 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: 6990873
• Report Number: 0002249697-2017-03163
• Device Sequence Number: 1196831
• Product Code: LPH
• UDI-Device Identifier: 07613327211825
• UDI-Public: 07613327211825
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 3715541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 12/26/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 01/18/2018
• 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