MAUDE Adverse Event Report: SYNTHES GMBH 6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number	04.632.640
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that this was an interbody fusion (l3, left) for stenosis on (b)(6)2023.The surgeon inserted the screw and tried to detach it from the holding sleeve, but it did not come off.The surgeon tried various methods, but the screw did not come off at all.The sales rep asked the surgeon to remove the screw once.Then, the surgeon inserted another screw using another holding sleeve.The inserted screw was detached from the holding sleeve with no problem.The defective holding sleeve could not be detached from the screw during surgery.When the sales rep tried to detach the holding screw from the screw after surgery, it did not come off at all with the usual detaching method, but the sale rep was finally able to detach them by repeated pulling, etc.After several attempts to detach and attach the holding sleeve and the screw, the screw would not come off the holding sleeve about 1 out of every 3 times.No further information is available.This report is for one (1) 6.0mm ti matrix polyax scrw 40mm th l.This is report 2 of 2 for complaint (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: d2: additional procodes: mni, kwp, nkb, kwq.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Sterile part: 04.632.640s sterile lot no: 8l50532 release to warehouse date:19 aug, 2021 expiry date: 01 aug, 2031 manufacturing site: werk selzach supplier: früh verpackungstechnik ag non-sterile part: 04.632.640 non-sterile lot: 69p2383 release to warehouse: 04 sep, 2020 manufacturing site: werk selzach supplier: synthes usa hq, inc the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the retain sleeve and polyaxial screw were returned in a disassembled condition.It was observed that the threads on the inner side of the polyaxial head were heavily stripped.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.A functional test revealed the retain sleeve was able to assemble to the polyaxial head of the screw.After that, the devices were disassembled without any sign of resistance.The complaint condition was not replicated.After a visual inspection per procedure, it was determined that the reusable instrument device was stripped from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.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 stripped of retain-6.0mm ti matrix polyax scrw 40mm th l, p/n: 04.632.640, lot: 69p2383 would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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 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: 6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 17107494
• Report Number: 8030965-2023-07377
• Device Sequence Number: 6070743
• Product Code: MNH
• UDI-Device Identifier: 10705034745527
• UDI-Public: (01)10705034745527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100952
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 04.632.640
• Device Catalogue Number: 04.632.640
• Device Lot Number: 69P2383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RETAIN-SLEEVE STD F/MATRIX 5.5
• Patient Sex: Unknown