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

Catalog Number 03.835.004

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that during inspection and the warehouse on an unknown date, it was discovered that the aiming device holder was jammed.There was no patient involvement.This report is for a 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.H3, h4, h6- there is a deformation at the front face of the inner sleeve.In general is the device is a very used condition.The sliding surface at the forefront of the inner sleeve is worn in the area of the balls.Both pins are deformed at the front side from assembling without respecting the assembling arrows.There are clearly visible hammer marks on top of the device.The device was jammed as complained when received.This jamming was caused by the deformation at the front face of the inner sleeve.During the evaluation it was possible to disassemble the devices with a hit with a hammer.After disassembling the resistance of the deformation was gone.The device was functional again and it could be assembled and disassembled as required.The complaint is confirmed as the device was received in a jammed condition.The evaluation has shown that this was caused by a deformation at the forefront of the inner sleeve.The used condition indicates that the device was previously functional as required and it can be therefore assumed that this deformation was caused post-manufacturing during use, for example by an hit from another instrument.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.Device history lot part: 03.835.004, lot: l677299, manufacturing site: hägendorf, release to warehouse date: 05.Dec.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 AIMING DEVICE HOLDER
• Type of Device: IMPACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9582985
• MDR Text Key: 190758694
• Report Number: 8030965-2020-00318
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 07611819677043
• UDI-Public: (01)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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• 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: L677299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1