MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM LCP SOLID THREADED DRILL GUIDE

Model Number	313.353
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2020, during an unknown procedure while the surgeon was drilling through the drill guide and dropped his hand to create an undesirable angle, the unknown drill bit broke off and was cold-welded in the drill guide.However, the drill guide was removed and the unknown drill bit was cold-welded in the drill guide.The screwdriver blade with holding sleeve was also damaged during the surgery.The star end of the shaft was twisted.The surgeon must have over torqued it.There was no surgical delay.Another unknown drill guide was used to complete the procedure successfully.There is no known patient consequence.This complaint involves three (3) devices.This report is for one (1) 2.0mm lcp solid threaded drill guide.This is report 1 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: the 2.0mm lcp solid threaded drill guide (p/n: 313.353 & lot # 8567547) was received at us cq with the broken drill bit struck inside the guide.This agrees with the reported complaint condition of unable to dis assemble both the devices, thus confirming the complaint.Functional test: a functional test could not be performed due to the disengagement of the devices returned.Dimensional inspection: due to the disengagement of the drill bit and the drill guide dimensional analysis could not be performed.Document/ specification review: based on the date of manufacture the following drawings, the current and manufactured revision of drawings were reviewed.Device failure/ defect identified? yes.Investigation conclusion: the complaint condition was confirmed for the 2.0mm lcp solid threaded drill guide (p/n: 313.353 & lot # 8567547).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities device history: part: 313.353.Lot: 8567547.Manufacturing site: hägendorf.Release to warehouse date: (b)(6) 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 LCP SOLID THREADED DRILL GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10080809
• Report Number: 2939274-2020-02479
• Device Sequence Number: 3852273
• Product Code: FZX
• UDI-Device Identifier: 10886982188182
• UDI-Public: (01)10886982188182
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2020

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: 313.353
• Device Catalogue Number: 313.353
• Device Lot Number: 8567547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 05/26/2020; 06/24/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 06/11/2020; 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STARDRIVE SCREWDRIVER SHAFT T8 105MM; UNK - DRILL BITS: TRAUMA