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 Information (3190)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Nurse at (b)(6) has reported the following to customer service.During surgery, today the instrument 2102-0410 broke into 2 pieces.The surgery proceeded by using another instrument.The surgery was delayed 15 minutes but no other consequences are reported for patient.

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 performed by the supplier noted the coupling adaptor attachment was broken off the body of the reamer handle.There were numerous areas of surface deformation observed throughout the complaint sample in the form of scratches and dents from general use.It was also observed that there was a large deformation around the area of the fracture.The fracture surface of the adaptor coupling observed under magnification suggests the part failed from wear due to 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 one other event for this lot.Conclusion: the returned device was shipped to the supplier, (b)(4), for evaluation.The supplier confirmed the event.The cause of the malfunction is attributed to wear as a result of torsional fatigue of the adaptor.

Event Description

Nurse at (b)(6) has reported the following to customer service.During surgery today the instrument 2102-0410 broke into 2 pieces.The surgery proceeded by using another instrument.The surgery was delayed 15 minutes but no other consequences are reported for patient.

• 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: 6115314
• MDR Text Key: 60690247
• Report Number: 0002249697-2016-03662
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/14/2017

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: V2009150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2010
• 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