MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CUP IMPACTOR BOLT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1440-2011

Device Problems Bent (1059); Insufficient Information (3190)

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

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Instruments failed during surgery, primary left hip.On (b)(6) 2015, sales rep reported that the flexible reamer is bent.It was being used for a total hip.Surgeon put the reamer in without a guide pin and when he pulled it up the reamer was bent.No adverse effect to patient related to reamer.On (b)(6) 2015, sales rep reported that the magnetic bolt is frozen to the impacting handle.

Manufacturer Narrative

An event regarding difficulty disassembling the cup impactor bolt from the da cup impactor handle (pr) was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as medical records were not received.Device history review: not performed as the lot details were not provided complaint history review: not performed as the lot details were not provided.Conclusions: it was not possible to determine the root cause of the event based on the information provided.Addtional information such as return of the device and operative notes are need to complete the investigation.No further investigation is possible at this time.If further information or device is received, this investigation will be reopened.

Event Description

Instruments failed during surgery, primary left hip on 11-nov-2015, sales rep reported that the flexible reamer is bent.It was being used for a total hip.Surgeon put the reamer in without a guide pin and when he pulled it up the reamer was bent.No adverse effect to patient related to reamer.On 9-nov-2015, sales rep reported that the magnetic bolt is frozen to the impacting handle.

• Brand Name: CUP IMPACTOR BOLT
• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5235471
• MDR Text Key: 31817969
• Report Number: 0002249697-2015-03917
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1440-2011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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