MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 1.8MM DRILL LONG W/AO QC; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71174906
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please notice this event was reported due to medwatch (b)(4).
Event or Problem Description
It was reported that during operation, drill bit was in use and broke inside the bone and was left in the place.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, without the return of the product for evaluation or the requested clinically relevant information, the root cause of the drill breakage cannot be determined.The alloy is neither bio-inert nor approved for implantation and it remains unknown if corrosion, micro-motion and/or migration of the retained fragments are likely.The patient impact beyond the reported retained non-implantable foreign bodies cannot be determined.No further clinical/medical assessment is warranted at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: 1.8MM DRILL LONG W/AO QC
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7851472
• Report Number: 1020279-2018-01732
• Device Sequence Number: 1567282
• Product Code: MDM
• UDI-Device Identifier: 00885556386590
• UDI-Public: 00885556386590
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71174906
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/21/2018; 08/21/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 09/14/2018; 11/06/2018
• 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
• Patient Age: 26 YR