MAUDE Adverse Event Report: SYNTHES GMBH DHS®/DCS® ONE-STEP INSERTION WRENCH

Model Number	338.302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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.
Event or Problem Description
Device report from new zealand reports an event as follows: it was reported that on (b)(6)2023 during a planned removal of a dhs, the incorrect handle was used.This caused the handle in question to break.The procedure was completed successfully.No further information is available to report.This report is for a dhs®/dcs® one-step insertion wrench.This is report 1 of 1 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: a manufacturing record evaluation was performed for the finished device.Product code: 338.302; lot number: 297p794.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 09/11/2021; manufacturing site: jabil bettlach.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo confirm the reported allegation.The distal tip of the dhs/dcs-wrench w/octagonal coupl f/one-s was found broken, fragment was not depict on the provided photo evidence.No other defects were observed.The surgical technique guide was reviewed and the following statement was found: warning: to avoid damaging the instruments and the implant, tighten the connecting screw securely.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for dhs/dcs-wrench w/octagonal coupl f/one-s.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.If information is obtained that was not available for this 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.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that dhs/dcs wrench was found with the distal tip broken, fragment was not received for evaluation.No other issue was identified.A dimensional inspection was not 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.The source controlled drawings reflecting the current and manufactured revisions were reviewed.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 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.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: DHS®/DCS® ONE-STEP INSERTION WRENCH
• Common Device Name: WRENCH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH; muracherstrasse 3; bettlach CO 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17350932
• Report Number: 8030965-2023-08955
• Device Sequence Number: 5091535
• Product Code: HXC
• UDI-Device Identifier: 10886982193315
• UDI-Public: (01)10886982193315
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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 Model Number: 338.302
• Device Catalogue Number: 338.302
• Device Lot Number: 297P794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 11/07/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/03/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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
• Patient Sex: Unknown