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	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.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 plif treating lumbar spondylolisthesis surgery.During the surgery, the surgeon while inserting a screw with the sleeve, the tip of the sleeve found chipped.Also, another tip breakage was found on the replaced sleeve.The surgery was completed less than 30-minutes delay.There were no fragments are remaining in the patient.The patient outcome was unknown.Concomitant device reported: unknown screw (part#: unknown, lot#: unknown, quantity: 2) this complaint involves two (2) devices.This report is for (1) holding sleeve-standard for matrix.This report is 2 of 4 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: h3, h6: 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.
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.H3, h6: part # 03.632.001; synthes lot # h717927; supplier lot # h717927; release to warehouse date: december 31, 2018; supplier: (b)(4).No ncrs were generated during production.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.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that retain-sleeve std f/matrix 5.5 tip of the device has broken off and the broken fragments were also returned.No other issues were identified.The dimensional inspection was not performed due to the post-manufacturing damage.The observed condition of the retain-sleeve std f/matrix 5.5 in the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed broken condition of the retain-sleeve std f/matrix 5.5.While no definitive root cause could be determined, it is probable that the retain-sleeve std f/matrix 5.5 was broken due to the unintended 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.Drawing/specifications reviewed? the following drawing reflecting the current and manufacture revision was reviewed: retaining sleeve matrix.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: 12116705
• Report Number: 8030965-2021-05513
• Device Sequence Number: 17042171
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2021

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: H717927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 08/03/2021; 08/09/2021
• Initial Report FDA Received Date: 07/05/2021
• Supplement Report FDA Received Date: 08/04/2021; 09/02/2021
• 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: RETAIN-SLEEVE STD F/MATRIX 5.5.; SCRDRIVERSHAFT T25 STD F/MATRIX 5.5.; SCRDRIVERSHAFT T25 STD F/MATRIX 5.5.; UNK - LOCKING/SET SCREWS.