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 Problem Appropriate Term/Code Not Available (3191)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

While removing a size 6 triathlon 4 in 1 cutting block one of the locating pins remained in bone.

Manufacturer Narrative

An event regarding crack/fracture involving an triathlon guide was reported.The event was confirmed.Method & results: -device evaluation and results: the device was returned in used condition, with the disassociated fixation pin.The other pin remained assembled.The disassociated pin appeared to have broken cleanly adjacent to weld zone.Material analysis was performed which concluded that "the pin broke from multiple overloads.The eds spectrum and hardness of the material were consistent with a 17-4 ph stainless steel alloy properly heat treated to the h900 condition.No material or manufacturing defects were observed." -medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: visual inspection confirms the reported event that concludes the device was returned in used condition, with the disassociated fixation pin.The disassociated pin appeared to have broken cleanly adjacent to weld zone.Material analysis was performed which concluded that "the pin broke from multiple overloads.The eds spectrum and hardness of the material were consistent with a 17-4 ph stainless steel alloy properly heat treated to the h900 condition.No material or manufacturing defects were observed." no further investigation for this event is possible at this time.If the additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

While removing a size 6 triathlon 4 in 1 cutting block one of the locating pins remained in bone.

• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5962657
• MDR Text Key: 55431379
• Report Number: 0002249697-2016-02991
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2016

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: SB2C18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2007
• 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: 60 YR
• Patient Weight: 115