MAUDE Adverse Event Report: SYNTHES GMBH HOLDING SLEEVE-STANDARD FOR MATRIX; MISC ORTHO SURGICAL INSTR

Catalog Number	03.632.001
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed, no product was received; 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a posterior spinal fusion at s1 left treating spondylolisthesis.During the surgery, the screw was not able to be tightened.The surgeon retried to connect the screw and the screwdriver out of the lesion, which was failed.A chipped fragment found after postoperative sterilization.The procedure was completed with less than 30 minutes delay.The patient condition was stable.This complaint involves three (3) devices.This report is for (1) t25 stardrive shaft f/matrix standard.This report is 3 of 3 (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).The product was returned to us cq for evaluation.The us cq team conducted the visual inspection of the returned device.Visual analysis of the returned sample revealed that a small portion of the inner sleeve component distal tip (threaded feature) was broken off.The dimensional inspection was not performed due to the post-manufacturing damage.The broken condition of the inner sleeve tip was consistent with a random component failure that may have been caused by exposure to unintended/overt forces.It should be noted that as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as visual inspection of the received device confirmed the broken condition.While no definitive root cause could be determined, it is possible that the alleged broken condition and functional issue may be occurred due to a random component failure that may have been caused by exposure to unintended/overt forces.There was no indication that a design or manufacturing issue contributed to the complaint.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.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Device history lot part # 03.632.001, synthes lot # 6705459, supplier lot # 6705459, release to warehouse date: nov 16, 2011, supplier: (b)(4), no ncr's were generated during production.Device history review 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-STANDARD FOR MATRIX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11727482
• Report Number: 8030965-2021-03286
• Device Sequence Number: 14207957
• Product Code: LXH
• UDI-Device Identifier: 07611819378056
• UDI-Public: 07611819378056
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 03.632.001
• Device Lot Number: 6705459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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: PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM; SCRDRIVERSHAFT T25 STD F/MATRIX 5.5