MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM DRILL BIT QC 170MM 80MM CALIBRATION; BIT, DRILL

Model Number	03.133.103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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) 2021, the tip of the drill bit broke off during insertion of the unk - screws: 3.5 mm cortex.The event occurred during an open reduction internal fixation (orif) of a left proximal tibia fx.The surgeon was drilling through the oblong hole of a 3.5mm lcp posteromedial plate using a 2.5mm drill bit with the 3.5mm non-locking drill guide.The angle of difficulty in relation to where the plate was positioned and how the leg was positioned made it difficult for the surgeon to aim the drill bit at the correct angle.He drilled through the oblong hole of the plate and into the near and far cortex without complication.As the surgeon backed out and retracted the drill bit from the far cortex, it was noticed that the tip of the drill bit was missing.An x-ray of the left proximal tibia showed that the tip of the drill bit was just anterior of the plate in the oblong hole of the 3.5 mm lcp posteromedial plate.The surgeon then took the plate off and proceeded to search for the missing tip of the 2.5mm drill bit.After suctioning, small needle-nose clamps were used in retrieving the missing tip of the 2.5mm drill bit.He then re-positioned the 3.5mm lcp posteromedial plate in the correct position and completed the case without any further complications.There was a ten (10) minute surgical delay.The surgery was completed successfully.The patient outcome was unknown.Concomitant device reported: 3.5mm non-locking drill guide (part# 03.133.002, lot# unknown, qty 1).Unk - screws: 3.5 mm cortex (part# unknown, lot# unknown, qty 1).This report is for one (1) 2.5mm drill bit qc 170mm 80mm calibration.This is report 1 of 2 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, or its employees caused or contributed to the potential event described in this report.Investigation summary: visual inspection: the 2.5 mm drill bit qc 170 mm 80 mm calibration was returned and received at us cq.Upon visual inspection, it was observed that the device was broken and the broken piece was returned.No other issues were identified with the returned device.Device failure/defect identified? yes.Complaint confirmed? yes.Investigation conclusion: the complaint condition is confirmed for the received device.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 during its use.No new malfunctions were observed during this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: the dhr could not be completed for the part/lot combination.If the lot number can be confirmed, the dhr will be revisited.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.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: 2.5MM DRILL BIT QC 170MM 80MM CALIBRATION
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12728010
• Report Number: 2939274-2021-06387
• Device Sequence Number: 12658712
• Product Code: HTW
• UDI-Device Identifier: 10886982269621
• UDI-Public: 10886982269621
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.133.103
• Device Catalogue Number: 03.133.103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5 LCP POSOMED PROXIMAL TIBIA PL 1H/69.; 3.5MM NON-LOCKING DRILL GUIDE.; UNK - SCREWS: 3.5 MM CORTEX.; 3.5 LCP POSOMED PROXIMAL TIBIA PL 1H/69; 3.5MM NON-LOCKING DRILL GUIDE; UNK - SCREWS: 3.5 MM CORTEX
• Patient Sex: Unknown