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

Model Number 03.835.004

Device Problem Compatibility Problem (2960)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.There was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.(other): without a valid part and lot number, the udi is not available.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.

Event Description

It was reported that one (1) synfix evolution aiming device holder comes apart but does not go back together.This was discovered when the synfix evolution instrument set was shipped to the sales consultant for a case on (b)(6) 2018.The set had been sent out for a case on (b)(6) 2018 and was returned to (b)(4) distribution center, inspected, and sent out again for cases on (b)(6) and (b)(6) 2018.The set was returned again, inspected and sent out for a case on (b)(6) 2018.There was no patient or case impact with the (b)(6) 2018 surgery.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: SYNFIX® EVOLUTION AIMING
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7936097
• MDR Text Key: 122806806
• Report Number: 2939274-2018-54170
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10705034814100
• UDI-Public: (01)10705034814100
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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