MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM RECONSTRUCTION PLATE 8 HOLES/94MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	245.18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s identifier and weight are unknown.Date of postoperative plate breakage is unknown.Additional device product code: ktw.Date of original implant is unknown.Complainant device is not expected to be returned for manufacturer.Review/investigation.Customer is retaining the product.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 reported that a patient was treated in (b)(6) on an unknown date for a right radius fracture.On a subsequent unknown date, the patient presented to the surgeon complaining of wrist pain.X-rays taken on an unknown date identified a broken plate.Right radius hardware removal and revision surgery was performed on (b)(6) 2017.A broken 8-hole lc-dcp (limited contact dynamic compression plate) reconstruction plate and six intact 3.5mm cortex screws (non-self-drilling) were removed.Patient was revised to a metaphyseal plate.There was no surgical delay, no retained fragments, and the procedure was completed.The patient outcome was stable.There is one device involved in this complaint.Reported concomitant devices: 3.5mm cortex screws, non-self-drilling (part # unknown, lot # unknown, quantity 6).This report is for one (1) 3.5mm reconstruction plate 8 holes/94mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.5MM RECONSTRUCTION PLATE 8 HOLES/94MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7110596
• Report Number: 2939274-2017-50228
• Device Sequence Number: 1091901
• Product Code: KWP
• UDI-Device Identifier: 10886982169761
• UDI-Public: (01)10886982169761(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K982322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 245.18
• Device Catalogue Number: 245.18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR