MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM; MISC ORTHO SURGICAL INSTR

Catalog Number	02.111.501.10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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.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 report that during an original surgery on (b)(6) 2018 for treatment of a distal radius fracture, patient was implanted with one (1) 2.4mm variable angled locking compression plate (va lcp) plate and six (6) unknown screws.The screws were a combination of both cortex and va locking screws.It is not known how many of each was implanted.During the procedure, while the surgeon was using the 1.25mm plate reduction wire to secure the plate for correct bone reduction, the reduction wire broke in half, into two pieces.The wire broke off right above the plate reduction device.A piece of the wire was temporarily inside the patient, but was successfully removed.Surgeon removed the wire and chose another one that was available in the operating room to complete the bone fixation.Surgery was completed successfully with a two (2) minute time delay.Patient is reported in stable condition.Concomitant devices reported: 2.4mm va lcp dorsal distal radius plate (product number 02.115.540, lot number unknown, quantity 1), cortex screws (part number unknown, lot number unknown, quantity unknown), locking screws (part number unknown, lot number unknown, quantity unknown) this report is for one (1) 1.25mm plate reduction wire this is report 1 of 1 for (b)(4).

• Brand Name: 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7639626
• Report Number: 2939274-2018-52642
• Device Sequence Number: 2324288
• Product Code: LXH
• UDI-Device Identifier: 20886982031706
• UDI-Public: (01)20886982031706
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/04/2018

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: 02.111.501.10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR