MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION AIMING DEVICE HOLDER; IMPACTOR

Model Number 03.835.004

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device received.A review of the device history record.Device history lot.Part: 03.835.004.Lot: l094646.Manufacturing site: hägendorf.Release to warehouse date: 20.Sep.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified investigation summary complaint summary: libertas: it was reported on (b)(6) 2020, the reduction forceps with points ratchet and synfix® evolution aiming were noted to not functioning.Flow: device interaction/functional visual inspection: the synfix® evolution aiming device holder (part # 03.835.004, lot # l094646, mfg # 20-sep-2016) was received at us cq with no visual defects.Functional test: a functional test was performed, and the device holder is stiff and very difficult to operate.This is consistent with the reported complaint condition; the complaint was able to be replicated.Therefore, the complaint is confirmed.Dimensional inspection: dimensional analysis was not performed as relevant features that determine functionality are not accessible.Document/specification review: conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative 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.

Event Description

Libertas: it was reported on (b)(6) 2020, the reduction forceps with points rachet and synfix® evolution aiming were noted to not functioning, depth gauge for mini screws was obsolete and other depth gauge was noted to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: SYNFIX® EVOLUTION AIMING DEVICE HOLDER
• Type of Device: IMPACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• 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: 9739792
• MDR Text Key: 191307370
• Report Number: 2939274-2020-00979
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10705034814100
• UDI-Public: (01)10705034814100
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.835.004
• Device Catalogue Number: 03.835.004
• Device Lot Number: L094646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1