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

Catalog Number 2102-0410

Device Problems Loss of or Failure to Bond (1068); Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The base of the reamer shaft broken off near the connection point while the surgeon was reaming the acetabulum.

Manufacturer Narrative

An event regarding fracture involving an acetabular reamer handle was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection noted the coupling adaptor attachment was broken off the body of the straight reamer handle.There was major surface deformation and material displacement the power coupling adaptor.A large amount of displaced material on the ratchet mating surfaces suggests there was some movement, during use, between the ratchet and the mating surface.The fracture surface of the adaptor coupling observed under magnification suggests the part failed from torsional fatigue.-medical records received and evaluation: not performed as it was reported there was no patient impact.-device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been no other events for this lot.Conclusion: the reported event was confirmed as the device was returned with the adaptor attachment broken off.The fracture surface of the adaptor coupling observed under magnification suggests the part failed from torsional fatigue.

Event Description

The base of the reamer shaft broken off near the connection point while the surgeon was reaming the acetabulum.

• Brand Name: ACETABULAR REAMER HANDLE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTEDST
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6100725
• MDR Text Key: 60248928
• Report Number: 0002249697-2016-03579
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 2102-0410
• Device Lot Number: V10321001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other