MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SINGLE USE INSTRUMENTS - FEMORAL KIT (CR) - SIZE 7; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5555-2207

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problems Abrasion (1689); No Consequences Or Impact To Patient (2199)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the surgeon that the single use instrumentation shows strong abrasion and pieces broke off at the single use femur prothesis.The piece which broke off could be removed from the patient.

Manufacturer Narrative

An event regarding crack/fracture involving a single use instruments ¿ femoral kit (cr) size 7 was reported.Method & results: -device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 02-nov-2015.It was reported and concluded that damage to the posterior cutting guide slots was observed and most likely caused from associated oscillating cutting blade activated prior to cutting blade insertion into the slots.Conclusions: the investigation concluded that damage occurred most likely due to contact with oscillating cutting blade prior to cutting blade insertion into the slots.The surgical protocol specifically recommends fully inserting the saw blade into the slot prior to initiating oscillation.There is no indication the event was related to the design manufacturing or materials of the subject device.

Event Description

It was reported by the surgeon that the single use instrumentation shows strong abrasion and pieces broke off at the single use femur prothesis.The piece which broke off could be removed from the patient.

• Brand Name: SINGLE USE INSTRUMENTS - FEMORAL KIT (CR) - SIZE 7
• 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: 5180429
• MDR Text Key: 30035747
• Report Number: 0002249697-2015-03457
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K132624
• 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: 09/28/2015

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: 5555-2207
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other