MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM UNIVERSAL DRILL GUIDE

Catalog Number	323.201
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used in a veterinary case ¿ no patient information will be reported.Date of event: unknown.Device is an instrument and is not implanted/explanted.Part 323.201, lot 5089342: manufacturing location: (b)(4).Release to warehouse date: october 20, 2005.The device history record shows this lot devices 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.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A service and repair investigation was completed: the customer reported the drill guide was missing a spring.The repair technician reported the spring was missing, and the 2.0 fixed end was damaged.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.A product investigation was completed: upon visual inspection, it was observed that the 2.00 mm universal drill guide was missing a compression spring component which agrees with the reported complaint condition.It was also observed that the 2.0 mm drill guide sleeve had an impact mark proximal to the teeth.The 2.00 mm universal drill guide shows signs of minimal wear and no other issues have been identified.The received condition agrees with the complaint description.The relevant drawings were reviewed.No design or manufacturing defect or deficiency was observed during the investigation.Dimensional analysis was performed and was falls within the specification.The complaint condition is confirmed.Regarding the missing spring, no definitive root cause could be determined, the most likely cause is disassembly of the device for sterile processing and misplacing the spring.Regarding the deformation of the 2.5 mm drill sleeve, the most likely cause for the impact mark on the drill sleeve is rough handling or excessive pressure on the device during use causing the cannulated thin wall tubes to deform.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.
Event or Problem Description
It was reported that on an unknown date, 2.0 mm universal drill guide was noted to be missing a spring.It is unknown if there was a procedure involved.This is a veterinary complaint; there is no human patient involvement.This is report 1 of 1 for (b)(4).

• Brand Name: 2.0MM UNIVERSAL 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: 7824693
• Report Number: 2939274-2018-53527
• Device Sequence Number: 1351274
• Product Code: FZX
• UDI-Device Identifier: 10886982190772
• UDI-Public: (01)10886982190772
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/29/2018

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: 323.201
• Device Lot Number: 5089342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1