MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0MM DRILL W/QC; PLATE, FIXATION, BONE

Catalog Number	71173501
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the tip of the drill broke and was left in the patient in the humeral canal.The surgery continued without delay with a replacement drill bit.
Additional Manufacturer Narrative
New additional information that was received for this case.
Event or Problem Description
It was reported that during surgery the tip of the drill broke and was left in the patient in the humeral canal due to the surgeon decided that it could cause more damage to retrieve the broken piece than left it inside the patient.The surgery continued without delay with a replacement s&n drill bit and the final outcome of the patient was great.
Additional Manufacturer Narrative
The associated complaint device was not returned.The medical evaluation concluded that, without the product return for evaluation, the root cause of the reported drill tip breakage cannot be concluded.The material composition of the retained drill tip is reported as a martensitic stainless steel, 440a, which is noted in the astm f 988-2002 as an alloy that is utilized in medical devices.This alloy is neither bio-inert nor approved for implantation.However, according to the surgeon, it could cause more damage to retrieve the broken piece than to leave it inside the patient.In addition, micro-motion and/or migration of the retained fragments is unlikely since the tip in in the humeral canal.Per report, the patient is doing great.Therefore, no further clinical medical assessment is warranted at this time.Without the actual device involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: 2.0MM DRILL W/QC
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8448489
• Report Number: 1020279-2019-01156
• Device Sequence Number: 2925874
• Product Code: HRS
• UDI-Device Identifier: 03596010519696
• UDI-Public: 03596010519696
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2019

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: 71173501
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 04/24/2019; 04/24/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/25/2019; 09/04/2019
• 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