MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT Ø2.5X125MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	700347
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Disposition is unknown.
Event or Problem Description
The drill bit broke off during surgery.
Additional Manufacturer Narrative
Correction: (lot #).The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided despite multiple attempts.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the reported lot number was incorrect.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The drill bit broke off during surgery.
Additional Manufacturer Narrative
Please be aware that as per further received information it was confirmed that reported event is related to ortho solutions laboratory drill not a stryker drill.Based on that information mfr report # 0008031020-2019-00335 is considered to be closed.
Event or Problem Description
The drill bit broke off during surgery.

• Brand Name: DRILL BIT Ø2.5X125MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8461815
• Report Number: 0008031020-2019-00335
• Device Sequence Number: 16479020
• Product Code: LXH
• UDI-Device Identifier: 04546540368973
• UDI-Public: 04546540368973
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2019

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: 700347
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/16/2019; 05/09/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/06/2019; 05/09/2019
• 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: 30 YR