MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE #7 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR.; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-1-707E

Device Problems Break (1069); Crack (1135); Fracture (1260); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

One spike of size 7 cutting block broke while taking off of femur.

Manufacturer Narrative

An event regarding a break involving a triathlon instrument cutting guide was reported.The event was confirmed.Method & results: device evaluation and results: inspection of the returned device confirmed the break of cutting block.Medical records received and evaluation: not performed as no medical records were available.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 break involving a triathlon instrument express 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 pin 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

One spike of size 7 cutting block broke while taking off of femur.

• Brand Name: SIZE #7 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5912492
• MDR Text Key: 54158411
• Report Number: 0002249697-2016-02780
• 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: Initial,Followup
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-1-707E
• Device Lot Number: SB3K07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2008
• 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 Age: 70 YR