MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOW PROFILE RECONSTRUCTION PLATE 16 HOLES; PLATE, FIXATION,BONE

Model Number	245.036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: ktt.Date of original implant was sometime in 2017.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The patient underwent a removal of hardware and an open reduction internal fixation (orif) with a new low profile reconstruction plate, bone graft and reamer/irrigator/aspirator (ria) due to a nonunion pelvis and a broken device.There were fragments that have been generated and it was easily removed.There was no surgical delay.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 removal of hardware and an open reduction internal fixation (orif) with a new low profile reconstruction plate, bone graft and reamer/irrigator/aspirator (ria) due to a nonunion pelvis and a broken device.There were fragments that have been generated and it was easily removed.There was no surgical delay.The procedure was completed successfully.The patient status is stable.This complaint involves two (2) devices.This report involves one (1) 3.5mm low profile reconstruction plate 16 holes.This report is 2 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.Awareness date for previous follow up report should have been february 05, 2019 not march 01, 2019.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.
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.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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
Note: patient returned to surgery for the revision on (b)(6) 2019.It was reported that patient had previous surgery elsewhere.

• Brand Name: 3.5MM LOW PROFILE RECONSTRUCTION PLATE 16 HOLES
• Common Device Name: PLATE, FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8283321
• Report Number: 2939274-2019-56105
• Device Sequence Number: 2080835
• Product Code: HRS
• UDI-Device Identifier: 10886982169501
• UDI-Public: (01)10886982169501
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K031573
• 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,Followup
• Report Date (Section B): 01/08/2019

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: 245.036
• Device Catalogue Number: 245.036
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 03/01/2019; 02/21/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/20/2019; 02/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Weight: 67