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 Break (1069); Detachment Of Device Component (1104); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Bone Fracture(s) (1870); Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a right primary knee surgery, upon removal of the #6 4 in 1 cutting block, the peg broke off and was left in the patient's bone.The piece was immediately retrieved without any delay and the case completed without any other events.

Manufacturer Narrative

An event regarding pin dissociation of a triathlon 4:1 express cutting 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.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 express 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

It was reported that during a right primary knee surgery, upon removal of the #6 4 in 1 cutting block, the peg broke off and was left in the patient's bone.The piece was immediately retrieved without any delay and the case completed without any other events.

• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5138371
• MDR Text Key: 28077080
• Report Number: 0002249697-2015-03275
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/18/2015

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: 6541-1-706E
• Device Lot Number: SB3M86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2009
• 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: 53 YR
• Patient Weight: 105