MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM DRILL BIT/QC/125MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Model Number	310.21
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes hsz, gfa, gff.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.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 on (b)(6) 2018, the drill bit was broken during an open reduction internal fixation of distal humerus procedure.The broken drill bit piece was left inside the right distal humerus.Surgical outcome was successful.Patient outcome was good.This report is for one (1) 2.0mm drill bit/qc/125mm this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes.Part: 310.21; lot: h610943; part manufacturing date: april 04, 2018; manufacturing site: elmira; part expiration date: n/a; nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h610943 of 2.0mm drill bits was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the component device history record(s) determined the component lot h580879 met all specifications with no issues documented that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h533270 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Flow: broken visual inspection: the 2.0 mm drill bit was received at us cq with the distal tip of the drill bit broken.This agrees with the reported complaint condition, thus confirming the complaint.The embedded portion of the device could not be confirmed since no x-rays were received at us cq.Dimensional inspection: dimensional analysis was completed; the overall length measured 106 mm.Therefore, approximately 11mm of the distal tip of the drill bit broke off.The diameter of the drill bit at the fracture site measured 2mm.This is within specification of 1.97 mm to 2.00 mm, based on drawing.Document/specification review: the following drawing(s) was reviewed; drill bit 2-flute dx.X ¿ d4.4 drill bit for quick coupling a review of the component device history record(s) determined the component lot h580879 met all specifications with no issues documented that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h533270 met all specifications with no issues documented that would contribute to this complaint condition.Conclusion: the complaint condition is confirmed as the drill bit was received with the distal tip broken.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 2.0MM DRILL BIT/QC/125MM
• 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: 7935627
• Report Number: 2939274-2018-54162
• Device Sequence Number: 1514537
• Product Code: HWE
• UDI-Device Identifier: 10886982186188
• UDI-Public: (01)10886982186188
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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 Model Number: 310.21
• Device Catalogue Number: 310.21
• Device Lot Number: H610943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 11/05/2018
• 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