MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.8MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE

Catalog Number	03.110.000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 an unknown date, during an unknown procedure, the drill bit would not fit through universal variable angle (va) locking drill guide.The surgeon went to drill through the nominal angle of the drill guide but was not successful despite switching drill bits.It appears the nominal angle part of drill guide was damaged.A different drill guide was used.It is unknown if the procedure was completed successfully.There was no surgical delay noted.No patient consequence reported.Concomitant devices reported: unknown drill bit (part #, unknown, lot# unknown, quantity # unknown).This is report 1 of 1 for complaint (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.A review of the device history records has been requested.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.
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.A device history record (dhr) review was conducted for part: 03.110.000, lot: l321397: manufacturing site: haegendorf, release to warehouse date: 13.Mar.2017: the device history record shows this lot of 50 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was completed.Visual inspection: the 1.8 mm universal variable angle locking drill guide (part # 03.110.000, lot # l321397, mfg # 13-mar-2017) was inspected at us cq.Upon visual inspection, it was observed that the inner circumferential surface of the coaxial tip slot which is proximal to the handle was damaged/deformed.The 1.8 mm universal variable angle locking drill guide shows signs of minimal wear and no other issues have been identified.The received condition agrees with the complaint description.Functional test: the 1.8 mm drill bits were not returned, but the functional inspection was performed with 1.79 & 1.81 mm gauge pins (gp32), and the gauge pins were not able to pass through the damaged coaxial tip slot.This confirms the complaint condition.Dimensional inspection: dimensional analysis was performed on the drill guide and the diameter of the coaxial tip slot proximal to the damaged portion measured and it falls within the specification based on the relevant drawing.Document/specification review: the relevant drawing(s) was reviewed; no design or manufacturing defect or deficiency was observed during the investigation.A device history review was performed for the returned instrument¿s lot number and no ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Investigation conclusion: the complaint condition is confirmed.While no definitive root cause could be determined, it is possible that the device encountered unintended forces during its usage at the time of surgery while trying to insert the drill bit into the coaxial tip slot.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: 1.8MM UNIVERSAL VARIABLE ANGLE 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: 7777881
• Report Number: 2939274-2018-53300
• Device Sequence Number: 11189000
• Product Code: FZX
• UDI-Device Identifier: 10886982071804
• UDI-Public: (01)10886982071804
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 07/26/2018

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 Catalogue Number: 03.110.000
• Device Lot Number: L321397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 09/18/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/14/2018; 09/19/2018
• 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: THERAPY DATE UNKNOWN