MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 1.5MM DRILL BIT/MINI QC/65MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number	310.141
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: gfa, gff, hsz.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during an open reduction internal fixation (orif) of the radius on (b)(6) 2017, 1.5mm drill bit / mini broke.The fragment still remains in the patient.There is no report of surgical delay or patient harm.Surgery completed successfully.The patient outcome was reported as stable.Concomitant devices reported: 2.0mm titanium cortex screw self-tapping 14mm (401.814.96, lot unknown, quantity 1).(b)(4).
Additional Manufacturer Narrative
Dhr review completed.Part # 310.141 synthes lot # u250735 supplier lot # (b)(4) expiration date: n/a release to warehouse date: 05 aug 2016 supplier: (b)(4) no ncr¿s were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.The returned drill bit (part 310.141, lot u250735, mfg 05 aug 2016) was inspected at customer quality and the complaint was confirmed.Whether this complaint could be replicated is not applicable because the device was returned broken.The following were performed to complete the investigation.¿ visual inspection ¿ device history record review ¿ drawing review ¿ dimensional analysis material and hardness testing is not applicable at this time as they were tested at the time of manufactured and confirmed to have no issues through the dhr review.Upon visual inspection, the drill bit was noted to be broken.Fragment was not returned.Dhr review showed no ncr¿s were generated during production.Drawing (current and mfg) was reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The diameter of the shaft closest to the break was measured to be with in the specification of 1.475 to 1.50mm at 1.49mm based on drawing.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition therefor no further corrective and preventive actions are proposed.Due to the serious injury design and clinical risk management (dcrm) document was reviewed.The complaint is adequately addressed by the risk assessment.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.5MM DRILL BIT/MINI QC/65MM
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7126635
• Report Number: 2939274-2017-50356
• Device Sequence Number: 1466692
• Product Code: HWE
• UDI-Device Identifier: 10886982185983
• UDI-Public: (01)10886982185983(10)U250735
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2017

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: 310.141
• Device Lot Number: U250735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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: Required Intervention
• Patient Age: 33 YR