MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SINGLE LOCKING DRILL GUIDE

Model Number	387.286
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is synthes sales consultant.A product investigation was conducted.Visual inspection: upon evaluation of the returned device at customer quality (cq), it was observed that one of the distal flanges sheared off at its base and was not returned.Therefore, this complaint is confirmed.Whether this complaint can be replicated at customer quality (cq) via functional test is not applicable for this complaint condition as the returned device is already broken.Mre: a review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.Review of raw material certificate could not be established during this review due to the age of the device (over 13 years old).The single locking drill guide (part 387.286) is part of the cervical spine locking plate (cslp) variable angle (va) system that is indicated for internal anterior fixation of the spine (c2-t2) for the management of fractures, degenerative disorders.The single locking drill guide is used for the insertion of fixed or variable angle bicortical screws into csl plates.Dimensional analysis: a dimensional inspection was not performed at cq because the distal flange sheared off at its base (transition to a different geometry/shoulder) and the sheared off tip fragment was not returned.Document specification: product drawing were reviewed during the investigation.The design and materials were found to be appropriate for the intended use of the device.One of the flanges has broken off at the shoulder.There could be several factors contributing to the incident.This device was made over 13 years ago, and over the years most likely accumulated stresses leading it to fatigue and break.Also, if excessive side load is imparted on the device, a cantilever force could cause a breakage.This could happen if the instrument is being used to manipulate the plate inside the wound.Conclusion: 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.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.A device history record (dhr) review was conducted: part number: 387.286, lot number: a7pa48 (wo# 911816), manufacturing site: (b)(4), release to warehouse date: 05-dec-2006.A review of the device history records was performed for the finished device lot number, and no non-conformance were identified.Review of raw material certificate could not be established during this review due to the age of the device (over 12 years old).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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the self-holding drill sleeve was bent and unable to allow full passage of the drill bit.It is unknown if when the issue was discovered.There was no patient involvement.This report is for one (1) single locking drill guide.This is report 1 of 1 for complaint (b)(4).

• Brand Name: SINGLE LOCKING 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: 8732742
• Report Number: 2939274-2019-58839
• Device Sequence Number: 11268224
• Product Code: FZX
• UDI-Device Identifier: 10705034770994
• UDI-Public: (01)10705034770994
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: 387.286
• Device Catalogue Number: 387.286
• Device Lot Number: A7PA48
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1