MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL FOR 20MM, 1,5X107.5MM, STRYKER, STERILE; INSTRUMENT

Catalog Number	91-15920
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Part of device in patient and the other was discarded.
Event or Problem Description
It was reported that during surgery the long drill bit was found to have the tip missing.An x-ray was ordered which identified the drill tip within the bone.At this time there is no medical intervention nor adverse consequence to report.

• Brand Name: DRILL FOR 20MM, 1,5X107.5MM, STRYKER, STERILE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7832906
• Report Number: 0008010177-2018-00077
• Device Sequence Number: 16478384
• Product Code: HBE
• UDI-Device Identifier: 04546540493712
• UDI-Public: 04546540493712
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K070876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 91-15920
• Device Lot Number: 6000013771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/30/2018
• 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