MAUDE Adverse Event Report: SYNTHES GMBH SYNFIX® EVOLUTION SCREWDRIVER

Catalog Number 03.835.010

Device Problems Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on an unknown date in 2021, the surgeon was tightening the screws in to the implant and the tip of the driver sheared off and remained in the wound site.The surgeon sucked the fragment up with the sucker and retrieved it later from the filter.There was no known patient consequence.This report is for one (1) synfix® evolution screwdriver.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.H3, h4, h6: part 03.835.010, lot 9916566: manufacturing site: werk hägendorf.Release to warehouse date: april 28, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a photo investigation was completed: the device was not returned.A photo-investigation was performed on the provided images.Upon inspecting all the images provided, the distal tip of the device was observed to be broken and the sheared piece is present in the image provided.Reported condition for the embedded device can't be confirmed as the x-rays are not provided.The root cause for the reported event cannot be determined from the available information.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.The complaint condition can be confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: isual inspection: the synfix evol scrdriver (part# 03.835.010, lot# 9916566 qty# 1) was returned and received at us customer quality (cq).Upon visual inspection, it is observed that the distal tip of the screwdriver had broken off.The broken piece was not returned.The reported condition of the broken fragment remaining in the wound cannot be confirmed as no post-operative radiographs were provided.No other issues were observed with the device.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to it being post manufacturing damage.Document/specification review: the following drawing(s) was reviewed: screw driver: current and manufactured revisions.No design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for the synfix evol scrdriver (part# 03.835.010, lot# 9916566 qty# 1).A definitive root cause could not be identified for the reported issue with the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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: SYNFIX® EVOLUTION SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12362830
• MDR Text Key: 268053476
• Report Number: 8030965-2021-07157
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819658127
• UDI-Public: (01)07611819658127
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.835.010
• Device Lot Number: 9916566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/09/2021; 11/08/2021
• Supplement Dates FDA Received: 09/10/2021; 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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
• Treatment: UNK - SCREWS: SYNFIX EVOLUTION.