MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE-LONG FOR MATRIX; MISC ORTHO SURGICAL INSTR

Model Number	03.632.036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.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 during an l3-l5 transforaminal lumbar interbody fusion (tlif) on (b)(6) 2020, after the cages were inserted, the surgeon began inserting the bilateral pedicle screws from l3-l5.While inserting the l4 pedicle screws on the right side, the matrix holding sleeve was noticed to start striping at the distal tip where the threaded portion engages with the matrix headless screws.Another sleeve was used, and the screw was implanted without issue.The same thing happened on the next level l5 on the right.This time a small fragment broke off, however, all pieces were removed from the patient.A third sleeve was used, and the screws were placed without any issues.The procedure was successfully completed without a surgical delay.There was no patient consequence reported.Concomitant device reported: matrix pedicle screw (part # 04.639.745), unknown cage (part # unknown, lot # unknown, quantity unknown), unknown screwdriver shaft (part # unknown, lot unknown, quantity 1), unknown t-handle (part # unknown, lot # unknown, quantity 1).This complaint involves two (2) devices.This report is for (1) holding sleeve-long for matrix.This is report 01 of 02 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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.The holding sleeve-long for matrix (part # 03.632.036 / lot # h716585) was received at us cq.The very distal threads of the device were broken from its core.The distal threads also appeared to be stripped.Scratches/nicks were prevalent along the shaft of the device.The received condition was consistent with the complaint condition thus the complaint was confirmed.The overall complaint was confirmed for the received holding sleeve-long for matrix.Although no definitive root-cause can be determined its possible the device encountered unintended forces such as excessive torque while in use.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 #: 03.632.036, synthes lot number: h716585, supplier lot #: h716585, release to warehouse date: 20-apr-2019, supplier: (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.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: HOLDING SLEEVE-LONG FOR MATRIX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10315695
• Report Number: 2939274-2020-03280
• Device Sequence Number: 19407538
• Product Code: LXH
• UDI-Device Identifier: 10705034718941
• UDI-Public: (01)10705034718941
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/04/2020

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: 03.632.036
• Device Catalogue Number: 03.632.036
• Device Lot Number: H716585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 07/04/2020
• Supplement Date Received by Manufacturer: 08/07/2020; 08/21/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/20/2020; 08/25/2020
• 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: 7.0MM TI MATRIX SCREW 45MM THREAD LENGTH; UNK - CAGE/PLATE; UNK - HANDLES; UNK - SCREWDRIVERS: SHAFTS