MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; INSTRUMENT

Catalog Number UNK_REC

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that surgeon was performing a left total hip - direct anterior approach and when surgeon impacted the cup, the impactor bolt was stuck in the cup.Surgeon had to remove the cup and implant a new cup using another impactor and bolt to complete the case.Surgeon implanted a new cup and used screws to secure.5-10 minute delay in surgery no additional anesthesia required.

Manufacturer Narrative

An event regarding difficulty disassembling a da impactor bolt from a shell was reported.The event was confirmed.Method & results:-device evaluation and results: a function analysis confirmed the bolt showed some resistance during assembly.This is not unexpected as some damage was noted on the threads.It is unclear when the thread damage occured.-medical records received and evaluation: not performed as patient factors did not contribute to the reported event.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no previous reported events for this lot id.Conclusions: it was determined that no manufacturing non-conformities were identified.However, this device is in scope of a non-conformance report to further investigate the root cause of similar reported events.

Event Description

It was reported that surgeon was performing a left total hip - direct antererior approach and when surgeon impacted the cup, the impactor bolt was stuck in the cup.Surgeon had to remove the cup and implant a new cup using another impactor and bolt to complete the case.Surgeon implanted a new cup and used screws to secure.5-10 minute delay in surgery no additional anesthesia required.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4924838
• MDR Text Key: 22511080
• Report Number: 0002249697-2015-02404
• 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: health professional,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/26/2015

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: UNK_REC
• Device Lot Number: DC231693
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2013
• 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