MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR OFFSET QUICK CONNECT INSERTER; INSTRUMENT

Catalog Number 1020-1860

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

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

Event Date 03/24/2014

Event Type  malfunction  

Event Description

It was reported that dr (b)(6) implanted the accolade ii stem through a da approach.Stem was impacted to final position and inserter was removed.No problems.((b)(6) 2014) opening accolade ii pans on (b)(6) 2014 scrub nurse noticed impactor was broken.Was brought to my attention, i immediately asked to see post op films from (b)(6) 2014.It looks as though part of impactor is broken off in the accolade ii stem in the proximal end.X-rays were shown to dr (b)(6).He believes it is in there also.He is going to notify patient.(b)(6) has an occurrence report written also.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

Reported event: an event regarding a fractured accolade inserter was reported.The event was confirmed.Method and results: device evaluation and results: a visual inspection confirmed the reported fracture.No material or manufacturing defects were identified.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the investigation concluded that the observed fractured occurred in fatigue.No material or manufacturing defects were identified.

Event Description

It was reported that dr (b)(6) implanted the accolade ii stem through a da approach.Stem was impacted to final position and inserter was removed.No problems.(3.24.14) opening accolade ii pans on 3.26.14 scrub nurse noticed impactor was broken.Was brought to my attention, i immediately asked to see post op films from 3.24.14.It looks as though part of impactor is broken off in the accolade ii stem in the proximal end.X-rays were shown to dr (b)(6) he believes it is in there also.He is going to notify patient.Valley view has an occurrence report written also.

• Brand Name: MODULAR OFFSET QUICK CONNECT INSERTER
• Type of Device: INSTRUMENT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3761868
• MDR Text Key: 4483012
• Report Number: 0002249697-2014-01332
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1020-1860
• Device Lot Number: SC21107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2012
• 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: 76 YR
• Patient Weight: 100