MAUDE Adverse Event Report: SYNTHES GMBH SYNFIX EVOLUTION AIMING DEVICE HOLDER; IMPACTOR

Catalog Number 03.835.004

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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 (b)(6) reports an event as follows: it was reported that on an unknown date that after assembling the instrument as intended, it was impossible to take apart or use and was completely stuck.This was discovered during cleaning and sterilization.This report is for (1) synfix evolution aiming device holder.This is report 1 of 1 for (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.H10 additional narrative: updated data: h4.Investigation summary: visual inspection: the synfix evolution aiming device holder (p/n: 03.835.004, lot #: 9942546) was returned and received at us cq.Upon visual inspection, the core part was received assembled with the locking sleeve.There were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: during the functional test, the device failed to disassemble as the locking sleeve was stuck onto the core part.Can the complaint be replicated with the returned device? yes.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed: aiming device holder, core part cpl, silicon handle palm green cpl, handle.Complaint confirmed? yes, the device received was jammed.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the synfix evolution aiming device holder (p/n: 03.835.004, lot #: 9942546).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 history lot.Part # 03.835.004.Lot # 9942546.Release to warehouse date: 16 sep 2016.Manufacturer: hagendorf.No ncr's were generated during production.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.Corrected data: d9, g1, h3, h6.

• Brand Name: SYNFIX EVOLUTION AIMING DEVICE HOLDER
• Type of Device: IMPACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11967541
• MDR Text Key: 261270999
• Report Number: 8030965-2021-04731
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 07611819677043
• UDI-Public: 07611819677043
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.835.004
• Device Lot Number: 9942546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1