MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3/1.0MM DOUBLE DRILL SLEEVE FOR 1.3MM CRTX SCREWS/YELLOW; GUIDE

Model Number	03.130.125
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: synthes employee.The device was 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.
Event or Problem Description
It was reported that on an unknown date, the double drill sleeve (guide) came to sterile processing with the tip on the 1.0 mm side bent.The 1.0 mm side of the drill guide is bent not allowing the drill bit to slide smoothly through the guide.There was no patient involvement.Concomitant device reported: unk - drill bits: trauma (part # unknown, lot # unknown, quantity 1).This is report 1 for 1 (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 product investigation was conducted.Visual inspection: the 1.3/1.0mm double drill sleeve for 1.3mm crtx screws/yellow (p/n 03.130.125 lot 9564109) was received showing the shaft of the 1.0 mm drill sleeve component (60077538) bent.Three of the five yellow epoxy color markings were observed to be peeled off and missing, one on the side of the drill guide, one under the ø1.0 etch, and one under the ø1.3 etch.No other issues were identified with the returned components of the device.Dimensional inspection: feature: ø1.0 drill sleeve outer diameter, inner cannulation diameter were measured and are conforming per relevant drawings.Due to the deformation of the guide sleeve, the gage pin was unable to pass through the 1.0 mm drill guide sleeve cannulation.Document/specification review: during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the 1.3/1.0mm double drill sleeve for 1.3mm crtx screws/yellow (p/n 03.130.125 lot 9564109) as the shaft of the 1.0 mm drill sleeve component (60077538) was bent.Three of the five yellow epoxy color markings were observed to be peeled off and missing.While no definitive root cause could be determined for the bent condition, it is possible that the device encountered unintended/excessive forces and/or rough handling during device use.The peeled color markings are likely due to normal wear from consistent use and reprocessing over the part¿s lifetime.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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: 03.130.125, lot: 9564109.Manufacturing site: bettlach, release to warehouse date: 11.September 2015.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.

• Brand Name: 1.3/1.0MM DOUBLE DRILL SLEEVE FOR 1.3MM CRTX SCREWS/YELLOW
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8977053
• Report Number: 2939274-2019-60411
• Device Sequence Number: 16190140
• Product Code: FZX
• UDI-Device Identifier: 10886982075284
• UDI-Public: (01)10886982075284
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 08/11/2019

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: 03.130.125
• Device Catalogue Number: 03.130.125
• Device Lot Number: 9564109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 08/11/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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: UNK - DRILL BITS: TRAUMA