MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE EX-FIX ROD ATTCHMT/MULTI PIN CLAMP/MR-CONDITIONAL; APPLIANCE,FIXATION,NAIL

Model Number	390.003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Additional product code lxt.(other): without a valid part and lot number, the udi is not available.Explanted date: not explanted.Complainant device 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 reported that the patient underwent open reduction internal fixation (orif) of the tibia on (b)(6) 2018.The initial nonunion was caused by the severity of injury and comminution of bone fragments.No implants used in first stage fixation caused nonunion.First stage fixation was performed with (9) synthes large external fixator on (b)(6) 2018.Bone graft was harvested on (b)(6) 2018 using the ria system of which the ria drive shaft is a part.The choice to harvest bone graft from femur to apply it to tibia to promote fracture healing.None of the external fixator parts failed.No parts are available for return.This complaint involves nine (9) devices.This report is 3 of 9 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.Additional patient identifier: (b)(6).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.Corrected data: initial reporter name, telephone, email, and occupation.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 further reported that the reamer/irrigator/aspirator (ria) drive shaft was discovered to have a broken tip after the instruments were washed post-operatively.This report addresses the non-union which resulted in the revision surgery.Intraoperative issue with ria drive shaft is addressed in (b)(4).

• Brand Name: LARGE EX-FIX ROD ATTCHMT/MULTI PIN CLAMP/MR-CONDITIONAL
• 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: 7887321
• Report Number: 2939274-2018-53821
• Device Sequence Number: 11278112
• Product Code: KTT
• UDI-Device Identifier: 10886982197801
• UDI-Public: (01)10886982197801
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 390.003
• Device Catalogue Number: 390.003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR