MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DOUBLEDRILLGUIDE 3.5/2.5

Model Number	312.28
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part: 312.280.Lot: 2502340.Manufacturing site: bettlach.Release to warehouse date: 01.July 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Visual inspection: the double drill guide 3.5/2.5 (p/n: 312.280, lot #: 2502340) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was bent.The 2.5 mm drill bit was observed to be broken and was investigated under a different pi in the same pc.There were scratches on the device but has no impact on the functionality of the device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.Double drill guide 3.5/2.5 dia.Complaint confirmed? yes, the device received was bent.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the double drill guide 3.5/2.5 (p/n: 312.280, lot #: 2502340).There is no indication that a design or manufacturing issue has caused the issue 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 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 january 1, 2020, the drill bit broke inside of a drill guide and became stuck.It is unknown if there were fragments generated.Procedure outcome is unknown.There was no patient consequence.Concomitant devices: drill guide (part: 312.280, lot: 2502340, quantity: 1).This report is for a 2.5mm drill bit.This is report 2 of 2 for (b)(4).

• Brand Name: DOUBLEDRILLGUIDE 3.5/2.5
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9847257
• Report Number: 2939274-2020-01315
• Device Sequence Number: 740181
• Product Code: FZX
• UDI-Device Identifier: 10886982187703
• UDI-Public: (01)10886982187703
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/20/2020

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: 312.28
• Device Catalogue Number: 312.280-US
• Device Lot Number: 2502340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1