MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CUP IMPACTOR BOLT; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number 1440-2011

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/11/2015

Event Type  malfunction  

Event Description

The doctor screwed the bolt inserter from the da instrumentation in the trident cup.He used the offset cup impactor from the da instrumentation to impact the cup into the patient.After impacting the cup, he tried to unscrew the bolt from the cup and it would not unscrew.He had to take out the cup, use the other bolt and insert a different cup.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding difficulty disassembling a da impactor bolt from a shell was reported.The event was not confirmed.Method & results: -device evaluation and results: a function analysis confirmed the reported disassembly difficulty.Inspection of the device found no damage to the product.In addition, no manufacturing non-conformances were identified.-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.Corrective action/preventive action: an nc was opened on december-2014.All future corrective/preventative actions will be documented in the nc record.

Event Description

The doctor screwed the bolt insertor from the da instrumentation in the trident cup.He used the offset cup impactor from the da instrumentation to impact the cup into the patient.After impacting the cup, he tried to unscrew the bolt from the cup and it would not unscrew.He had to take out the cup, use the other bolt and insert a different cup.

Manufacturer Narrative

An event regarding difficulty disassembling a da impactor bolt from a shell was reported.The event was not confirmed.Method & results: -device evaluation and results: a function analysis did not confirm the reported disassembly difficulty.Inspection of the device found no damage to the product.In addition, no manufacturing non-conformances were identified.Visual inspection: a visual inspection of the returned device showed no signs of damage on the threads or the device body.Dimensional inspection: not performed as it was confirmed the device is within the scope of nc.Functional inspection: the devices were returned assembled.The bolt and the shell could easily be assembled and disassembled.Therefore, the reported event could not be confirmed.-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

The doctor screwed the bolt insertor from the da instrumentation in the trident cup.He used the offset cup impactor from the da instrumentation to impact the cup into the patient.After impacting the cup, he tried to unscrew the bolt from the cup and it would not unscrew.He had to take out the cup, use the other bolt and insert a different cup.

• Brand Name: CUP IMPACTOR BOLT
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• 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: 4665326
• MDR Text Key: 5625265
• Report Number: 0002249697-2015-01072
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• 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: DC247401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2014
• 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
• Patient Age: 67 YR
• Patient Weight: 81