MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL RESECTION GUIDE MODULAR CAPTURE RT; INSTRUMENT

Catalog Number 6541-2-702

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562); 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 03/25/2015

Event Type  malfunction  

Event Description

Customer reported that the pin separated from the instrument (went up) during surgery.Customer suspects that it became loose most probably during work of oscillating saw due to vibrations.As customer clarified it was not possible to pin it to the block, and in a consequence the delay in surgery was noted and the risk that it remains in patient's body occurred.As per the customer, there were no adverse patient consequences; surgery was completed successfully using another cutting block.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding a failed press fit pin involving a triathlon instrument was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection confirmed the event.The pin was dissociated from the device body.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: all devices manufactured into final stock conformed to specification.Complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the subject device has been identified as within the scope of (b)(4) and related capa (b)(4).A supplier manufacturing nonconformance has been identified and investigated under the referenced nc and capa records.

Event Description

Customer reported that the pin separated from the instrument (went up) during surgery.Customer suspects that it became loose most probably during work of oscillating saw due to vibrations.As customer clarified it was not possible to pin it to the block, and in a consequence the delay in surgery was noted and the risk that it remains in patient's body occurred.As per the customer, there were no adverse patient consequences; surgery was completed successfully using another cutting block.

• Brand Name: TIBIAL RESECTION GUIDE MODULAR CAPTURE RT
• Type of Device: INSTRUMENT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4712352
• MDR Text Key: 5746351
• Report Number: 0002249697-2015-01278
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-2-702
• Device Lot Number: RD6E155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other