MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE #6 4-IN-1 CUTTING BLOCK CAPTURED ASSY TRIA. EXP. INSTR.; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-1-706E

Device Problems Detachment Of Device Component (1104); Material Fragmentation (1261)

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

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Stryker sales rep reported that: "after using the instrument (size 6 4 in 1 cutting guide), ie after making the bone cuts, the surgeon removed this instrument and a part of the device remained in the patient's femur.This "peak" has been removed with a large forceps.This "peak" is an integral part of this instrument.".

Manufacturer Narrative

An event regarding pin disassociation involving a 4:1 cutting block was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned in used condition.The peg has disassociated from the device.There are minor scratches and abrasions in various areas of the device.Additional dimensional inspection was not performed as it was within the scope of the capa.Medical records received and evaluation: not performed as no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the investigation concluded that the fixation peg disassociating from the #6 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.During the review of the issue, it was identified that the original changes made to the pins and change made to the capture plate identified in the active part listing were not validated or verified to ensure no design issues were to occur.For the counter-bore and pin issue, a new fixturing system will be implemented at seabrook to assist in the assembly operation.The radius will be changed back to the original design and manufactured to specification moving forward.Stryker reserves the right to re-evaluate this investigation if additional relevant information becomes available.

Event Description

Stryker sales rep reported that: "after using the instrument (size 6 4 in 1 cutting guide), ie after making the bone cuts, the surgeon removed this instrument and a part of the device remained in the patient's femur.This "peak" has been removed with a large forceps.This "peak" is an integral part of this instrument.".

• Brand Name: SIZE #6 4-IN-1 CUTTING BLOCK CAPTURED ASSY TRIA. EXP. INSTR.
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6419659
• MDR Text Key: 70557381
• Report Number: 0002249697-2017-00958
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-1-706E
• Device Lot Number: SB3M41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2008
• 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