MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 1/8" PEG DRILL; BIT, DRILL

Catalog Number	6541-4-518
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon drill bit was reported.The event was not confirmed.Method & results: product evaluation and results: the device was not returned, however a single image of the drill bit was made available.The device appears intact with no obvious damage noted.Medical records received and evaluation: not performed as no medical records were returned for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been two other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return and the primary operative report are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Triathlon1 1/8th drill bit snapped while pre drilling hole for tibial headed pin.Seen by surgeon and rep during surgery.

• Brand Name: 1/8" PEG DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8198075
• Report Number: 0002249697-2018-04128
• Device Sequence Number: 13895659
• Product Code: HTW
• UDI-Device Identifier: 07613327241440
• UDI-Public: 07613327241440
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6541-4-518
• Device Lot Number: SC7C11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other