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

Catalog Number	03.632.036
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in australia as follows: it was reported that on (b)(6) 2022 a patient underwent a revision of life health care implants/screws replacing with synthes and extending.At beginning of the case during set up it was noted that one out of the two screw driver sleeve's thread was faulty (cannot load a screw on straight).Then during the procedure when surgeon was introducing the cannulated screw into the pedicle via guidewire, it was noted that the guidewire was stuck.The reported sleeve had advanced not only the screw but also the guidewire into the pedicle.The surgeon was able to remove the guidewire with some force and no harm was caused to patient.Upon inspection it was noted that the sleeve thread was out of place/faulty.Total of two driver sleeves were reported faulty during this case.There was a five (5) minutes of surgical delay.The procedure was successfully completed.This report is for one (1) holding sleeve-long for matrix.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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.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.H6: photo investigation: the photo was returned to depuy synthes for evaluation.Visual analysis of the photo revealed that the retain-sleeve long f/matrix 5.5 (p/n: 03.632.036, lot: 6719146) had the threads of the inner sleeve stripped which could be attributed to the unable to assemble condition reported.No other issues were identified.H3, h6: a product investigation was conducted.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 retain-sleeve long f/matrix 5.5 was broken at the threaded tip.The broken piece was not returned.A functional test was not performed due to the mating device not being returned.A dimensional inspection for the retain-sleeve long f/matrix 5.5 was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.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 condition of the retain-sleeve long f/matrix 5.5 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.H3, h6: a device history record (dhr) review was conducted: part # 03.632.036; synthes lot # 6719146; supplier lot # 6719146; release to warehouse date: october 27, 2011; manufactured by: magnum manufacturing centre.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.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: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14442944
• Report Number: 8030965-2022-03310
• Device Sequence Number: 6339971
• Product Code: LXH
• UDI-Device Identifier: 07611819379435
• UDI-Public: (01)07611819379435
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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: 03.632.036
• Device Lot Number: 6719146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 05/05/2022; 06/16/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 05/26/2022; 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWDRIVERS.; UNK - SCREWS.
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 97 KG