MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 1-3 KEEL PUNCH; INSTRUMENT

Catalog Number 6541-2-013

Device Problems Break (1069); Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

It was reported that the breakage of the keel punch was noticed before the medical procedure.So, spare product was used instead of it in the medical procedure.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding a dissociated dowel pin from a triathlon keel punch was reported.The event was confirmed.Method & results: -device evaluation and results: a visual inspection confirmed the reported event.The dowel pin was returned 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 accepted into final goods conformed to specification.-complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the investigation concluded that the dowel pin dissociating from the keel punch body was the result of a manufacturing nonconformance, where the keel punch body hole was oversized.

Event Description

It was reported that the breakage of the keel punch was noticed before the medical procedure.So, spare product was used instead of it in the medical procedure.

• Brand Name: SIZE 1-3 KEEL PUNCH
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4860481
• MDR Text Key: 5846188
• Report Number: 0002249697-2015-02015
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-2-013
• Device Lot Number: RD6T042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2011
• 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