MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 1/8" PEG DRILL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	6541-4-518
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
While pre-drilling tibial baseplate, 1/8 drill with the stop broke.Loose piece was found.No adverse consequences.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a 1/8¿ peg drill was reported.The event was not confirmed.Could not be performed as no items associated with the event were returned or made available for evaluation.Medical records received and evaluation: not performed as no medical records were provided.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been 01 other events found for this lot.The event could not be confirmed nor could the root cause be determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
While pre-drilling tibial baseplate, 1/8 drill with the stop broke.Loose piece was found.No adverse consequences.

• Brand Name: 1/8" PEG DRILL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6226790
• Report Number: 0002249697-2017-00096
• Device Sequence Number: 19023306
• Product Code: LXH
• UDI-Device Identifier: 07613327241440
• UDI-Public: (01)07613327241440(11)160513(10)SC8H02
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2017

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: SC8H02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 03/16/2017
• 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
• Patient Age: 69 YR
• Patient Weight: 90