MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH #6 4:1 CUTTING BLOCK; INSTRUMENT

Catalog Number 6541-1-706

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/15/2015

Event Type  malfunction  

Event Description

While removing the triathlon size 6 4:1 cutting block the peg on the 4:1 size 6 triathlon cutting block broke off of the block.It was removed from the patient and the surgery continued on without complication.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.

Manufacturer Narrative

Corrected data: manufacturing date.An event regarding pin dissociation of a triathlon 4:1 cutting guide was reported.The event was confirmed.Method & results: -device evaluation and results: inspection of the returned device confirmed the pin had dissociated from the device body.Additional dimensional inspection was not performed as it was confirmed the product was within scope of the associated capa.-medical records received and evaluation: not performed as there was no indication that patient factors contributed to the reported event.-device history review: all devices accepted into final stock conformed to specification.This review confirmed the device was manufactured prior to capa implementation.-complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the investigation concluded that the fixation peg disassociating from the triathlon 4:1 cutting block was caused by a manufacturing nonconformance.It was concluded that the supplier, seabrook international, had not performed the required press fit operation between the peg and block which led to the pin coming out of the assembly.Stryker reserves the right to re-evaluate this investigation if additional relevant information becomes available.

Event Description

While removing the triathlon size 6 4:1 cutting block the peg on the 4:1 size 6 triathlon cutting block broke off of the block.It was removed from the patient and the surgery continued on without complication.

• Brand Name: #6 4:1 CUTTING BLOCK
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4515783
• MDR Text Key: 20733308
• Report Number: 0002249697-2015-00319
• Device Sequence Number: 1
• Product Code: LXH
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2015

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: 6541-1-706
• Device Lot Number: SBZM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 02/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2006
• 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: 71 YR