MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP RECONSTRUCTION PLATE 7 HOLES/98MM; APPLIANCE,FIXATION,NAIL

Model Number	245.071
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 on (b)(6) 2019, the patient underwent a revision of hardware on the radius due to delayed healing and nonunion.The patient originally had both forearm bones fractured (radius and ulna).The locking compression plate (lcp) was applied to the ulna and a recon plate was applied to the radius in 2018.Post-operative on an unknown date, the recon plate was identified as bent and the fracture malreduced.The plate had to be removed and fracture fixed.Procedure and patient status are unknown.This complaint involves two (2) device.This report is for one (1) 3.5mm lcp reconstruction plate 7 holes/98mm.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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) 2019, patient underwent a revision surgery on the radius due to delayed healing and non-union.The patient originally had both bone forearm fractured.The locking compression plate (lcp) was applied to the ulna and a reconstruction plate was applied to the radius in 2018.The recon plate was observed to be bent and fracture malreduced.The malfunctioned plate was removed and fracture was fixed.The procedure was successfully completed with no surgical delay.Patient status was reportedly fine.

• Brand Name: 3.5MM LCP RECONSTRUCTION PLATE 7 HOLES/98MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8336022
• Report Number: 2939274-2019-56433
• Device Sequence Number: 11175220
• Product Code: KTT
• UDI-Device Identifier: 10886982169600
• UDI-Public: (01)10886982169600
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 245.071
• Device Catalogue Number: 245.071
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 03/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR