MAUDE Adverse Event Report: SYNTHES GMBH HOLDING SLEEVE-STANDARD FOR MATRIX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: initial reporter facility name: (b)(6) medical center.The device has been 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
Device report from synthes reports an event in (b)(4) as follows: it was reported that on (b)(6) 2021, during a plif at l5-s for treatment of spinal canal stenosis the screw split into the screwhead and shaft when the surgeon had to extract an inserted screw.The surgeon was able to remove the two fragments of the screw and the sleeve.It was confirmed that no fragments were left in the patient¿s body.There was a less than thirty (30) minute surgical delay.The procedure was completed and the patient was reported as stable.Concomitant devices reported: pedicscr matrix 5.5 polyaxial ø7 preassm (part number 04.632.740s, lot h641918, quantity 1) this report involves one (1) holding sleeve-standard for matrix.This is report 1 of 2 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.H3, h4, h6: the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the received device.Visual analysis of the returned sample revealed that a small portion of the distal threaded tip was broken off.The broken piece was received at us cq.The dimensional analysis was not performed due to the post-manufacturing damage.The broken condition of the distal threaded 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 spine¿s 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 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 device history lot : part # 03.632.001, synthes lot # 6705459, supplier lot # 6705459, release to warehouse date: 16 nov 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: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11259815
• Report Number: 8030965-2021-00754
• Device Sequence Number: 714964
• Product Code: LXH
• UDI-Device Identifier: 07611819378056
• UDI-Public: (01)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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: 01/25/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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 Ø7 PREASSM