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

Catalog Number 2102-0410

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

While in the process of reaming the acetabulum, the reamer shaft broke at the connection site to the drill.

Manufacturer Narrative

An event regarding crack/fracture involving a acetabular reamer handle was reported.The event was confirmed.Method & results: -device evaluation and results: the tip of the acetabular reamer handle broke in half.The broken piece was returned with the reamer handle.There are scratches in various areas of the device, which is consistent with use.Referenced pi 1099827, ¿the returned device is a source controlled device; evaluation was performed by the supplier, (b)(4).The supplier indicated: the fracture surface of the adaptor coupling observed under magnification is consistent with torsional fatigue, which may have been the result of excessive stresses or applied forces to the device.¿ -medical records received and evaluation: not performed as no medical records were received for review with a clinical consultant.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been 1 other event for the lot referenced.Conclusions: the investigation concluded that the tip of the acetabular reamer handle broke, based on the supplier¿s analysis ¿the fracture surface of the adaptor coupling observed under magnification is consistent with torsional fatigue, which may have been the result of excessive stresses or applied forces to the device.¿.

Event Description

While in the process of reaming the acetabulum, the reamer shaft broke at the connection site to the the drill.

• Brand Name: ACETABULAR REAMER HANDLE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 6120125
• MDR Text Key: 60937692
• Report Number: 0002249697-2016-03754
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161569
• 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: 01/20/2017

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: V25859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2009
• 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