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

Catalog Number 6541-1-704E

Device Problems Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384)

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

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During removing of the cutting block it was noticed that one pin was broken.Pin could be removed completely from the bone.

Manufacturer Narrative

Lot s85k31 corrected to sb5k31.An event regarding pin disassociation of a triathlon guide was reported.The event was confirmed.Method and 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 01 similar previous reported events for this lot id.Conclusions: the investigation concluded that the fixation peg disassociating from the triathlon cutting block was caused by a manufacturing nonconformance.It was concluded that the supplier, (b)(4), 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

During removing of the cutting block it was noticed that one pin was broken.Pin could be removed completly from the bone.

• Brand Name: SIZE #4 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: 6172213
• MDR Text Key: 62621656
• Report Number: 0002249697-2016-03917
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-1-704E
• Device Lot Number: SB5K31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2010
• 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