MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM ADJUSTABLE PARALLEL WIRE GUIDE

Model Number	312.01
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device returned.A review of the device history record.Device history lot part number: 312.01.Lot number: 6289695.Per jde, manufactured date: 12/30/2009.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.Investigation summary background: it was reported that on january 14, 2020, the 2.8 mm adjustable parallel wire guide had a stuck threaded nut not allowing the movable sleeve to lock into place during proximal femur using 7.3mm cannulated screw set.Action taken the surgeon attempted to free the stuck nut with pliers but was unsuccessful and proceeded with the surgery by using a freehand technique for inserting the wire.There was a surgical delay of one (1) minute.The procedure was successfully completed.The patient outcome as planned.Concomitant devices reported: unknown guides/sleeves/aiming: sleeve (part# unknown, lot# unknown, quantity# 1).This complaint involves one (1) device.Investigation flow: functional/device interaction.Visual inspection: the 2.8 mm adjustable parallel wire guide (p/n: 312.01, lot #: unk) was returned and received at us cq.Upon visual inspection, it was observed that the adjustable guide sleeve component (p/n: 312.01.4) was broken and the broken fragment was lodged into the locking nut.There were scratches on the device but have no impact on the functionality of the device.No other issues were identified with the returned device.Functional test: the functional test was not performed on the returned device due to the broken adjustable guide sleeve.The device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the 2.8 mm adjustable parallel wire guide (p/n: 312.01, lot #: unk).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 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 or Problem Description
It was reported that on january 14, 2020, the 2.8 mm adjustable parallel wire guide had a stuck threaded nut not allowing the movable sleeve to lock into place during proximal femur using 7.3mm cannulated screw set.Action taken the surgeon attempted to free the stuck nut with pliers but was unsuccessful and proceeded with the surgery by using a freehand technique for inserting the wire.There was a surgical delay of one (1) minute.The procedure was successfully completed.The patient outcome as planned.Concomitant devices reported: unknown guides/sleeves/aiming: sleeve (part# unknown, lot# unknown, quantity# 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 2.8MM ADJUSTABLE PARALLEL WIRE GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9936419
• Report Number: 2939274-2020-01760
• Device Sequence Number: 752486
• Product Code: FZX
• UDI-Device Identifier: 10886982187543
• UDI-Public: (01)10886982187543
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

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
• Operator of Device: Health Professional
• Device Model Number: 312.01
• Device Catalogue Number: 312.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1
• Patient Age: 13 YR