MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.25MM PLATE REDUCTION WIRE THRDD TIP W/SM STOP/150MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02.111.500.10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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 or Problem Description
It was reported that on (b)(6) 2021, during an unknown procedure, three depth gauges were broken in the process of measuring, the tips completely broke off.A total of seven wires broke off the olive tips, the cannulated screwdriver was broken, and two t8's were stripped.The parallel guide and countersink had rust residue on them.The procedure was successfully completed with no surgical delay.No patient consequence.Concomitant devices reported: 2.0/2.4mm depth gauge 50mm (part number sd319.006, lot unknown, quantity 1) cannulated countersink for 4.5mm cannulated screws (part number 310.85, lot unknown, quantity 1).Adjustable parallel wire guide (part number 312.73, lot unknown, quantity 1) cannulated 4.0mm hexagonal screwdriver (part number 314.05, lot unknown, quantity 1) stardrive screwdriver shaft t8 105mm (part number 314.467, lot unknown, quantity 1) 1.25mm plate reduction wire thrdd tip w/lrg stop/150mm (part number 02.111.501.10, lot unknown, quantity 1).1.6mm compression wire 15mm thread/150mm length (part number 03.211.415, lot unknown, quantity 1).2.0/2.4mm depth gauge 50mm (part number sd319.006, lot unknown, quantity 2).This report involves one (1) 1.25mm plate reduction wire thrdd tip w/sm stop/150mm.This is report 4 of 8 for (b)(4).This product complaint, (b)(4), is related to (b)(4).

• Brand Name: 1.25MM PLATE REDUCTION WIRE THRDD TIP W/SM STOP/150MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11378536
• Report Number: 2939274-2021-01043
• Device Sequence Number: 19768767
• Product Code: LXH
• UDI-Device Identifier: 80886982031678
• UDI-Public: (01)80886982031678
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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 Catalogue Number: 02.111.500.10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1