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	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a 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 (b)(6) 2019, the unknown wire was stuck in guide/double drill sleeve.Completed the procedure with back up device.There was no surgical delay.The procedure outcome was unknown.There was no patient consequence.This complaint involves two (2) devices.This is 1 of 2 for report (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.H10 additional narrative: g3: updated source professional info.G4: update date.H11: corrected information.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.H3, h4, h6- visual inspection: the 1.3/1.0mm double drill sleeve for 1.3mm crtx screws/yellow (part # 03.130.125 / lot # 9605220) and the unk - guide/compression/k-wires: trauma were received at us cq.The ø1.3 side of the double drill guide has the unknown wire stuck in it.The k-wire was broken in the sleeve, only the distal portion of the k-wire remained.Since the whole k-wire was not available, it was not possible to determine which specific k-wire was utilized.Attempts were made to disassemble the device but due to the jammed condition of the k-wire, the wire could not be removed.Dimensional inspection was not performed due to the stuck jammed condition of the k-wire blocking access to the internal components of the drill sleeve.The overall complaint was confirmed for the received 1.3/1.0mm double drill sleeve for 1.3mm crtx screws/yellow as the jammed k-wire was unable to be removed from the drill sleeve.Although no definitive root-cause can be determined, the device may have experienced unintended forces leading to the k-wire deforming within the mating sleeves hole.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history lot part: 03.130.125, lot: 9605220, manufacturing site: bettlach, release to warehouse date: 09.February 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: 9444401
• Report Number: 2939274-2019-62606
• Device Sequence Number: 2403130
• Product Code: FZX
• UDI-Device Identifier: 10886982075284
• UDI-Public: (01)10886982075284
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup,Followup
• Report Date (Section B): 01/07/2020

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: 03.130.125
• Device Catalogue Number: 03.130.125
• Device Lot Number: 9605220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 01/10/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/08/2020; 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1