MAUDE Adverse Event Report: SYNTHES GMBH DHS/DCS COUPLING SCREW; EXTRACTOR

Model Number 338.31

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.Complainant part is not expected to be returned for manufacturer review/investigation.Reporters state: (b)(6).Phone number: (b)(6).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 Description

Device report from depuy synthes reports an event in canada as follows: it was reported that the dhs instrument set was received in the decontamination room for cleaning prior to sterilization and passed to the instrument room for assembly.The instrument room technician noted that the tip of coupling screw was missing.The or was contacted and the scrub nurse, who unfortunately, threw out the tip.No surgical delayed due to this reported event.Procedure was successfully completed and fragments generated and were they removed easily without additional intervention.This complaint involves one (1) device.This report is for one (1) dhs/dcs coupling screw this is report 1 of 1 for complaint (b)(4).

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.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.

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.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.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.Part# 338.31.Synthes lot # ft00518.Supplier lot # ft00518.Release to warehouse date: 10 aug 2017.Supplier: (b)(4).No ncrs were generated during production.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 revealed that the dhs/dcs coupling screw was broken from the distal tip, fragment is not visible in the evidence provided.Missing components condition cannot be confirmed as the tip is part of the shaft.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 the dhs/dcs coupling screw.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.

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.Part # 338.31, synthes lot # ft00518, supplier lot # ft00518, release to warehouse date:10 aug 2017, supplier: (b)(4).No non conformance reports generated during production.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 dhs/dcs coupling screw was broken from the distal tip, broken fragment was not returned.Missing components condition cannot be confirmed as the tip is part of the shaft a dimensional inspection for the dhs/dcs coupling screw was not performed as it is not applicable to the complaint condition.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 dhs/dcs coupling screw 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.Drawing/specifications reviewed: the following source controlled drawings reflecting the current and manufactured revisions were reviewed: dhs / dcs coupling screw rev.F current/ rev.E manufactured.Dimensional inspection: n/a.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 COUPLING SCREW
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16755487
• MDR Text Key: 313496236
• Report Number: 8030965-2023-04769
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982193322
• UDI-Public: (01)10886982193322
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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
• Device Operator: Health Professional
• Device Model Number: 338.31
• Device Catalogue Number: 338.31
• Device Lot Number: FT00518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 04/17/2023; 05/05/2023; 05/22/2023
• Supplement Dates FDA Received: 04/18/2023; 05/11/2023; 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1