MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MAXFRAME(TM) FULL RING 150MM ALUMINUM; APPLIANCE,FIXATION,NAIL

Model Number	03.312.150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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.A review of the device history records has been requested.(b)(4).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 an unknown date, the maxframe full ring broke on the patients frame which was being used to treat a distal tibia fracture.The original implant procedure was on (b)(6) 2018.The broken ring was replaced on (b)(6) 2019, with a 150mm 5/8 ring and bridge plate.The patient also broke two (2) smooth wires and one (1) olive wires.The wires were also replaced with new ones.It is unknown it there was surgical delay.The procedure was successfully completed.Patient status is unknown.This report is for one (1) maxframe(tm) full ring 150mm aluminum.This is report 1 of 4 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.Device history part number 03.312.150, lot number: h420922, date of manufacture: 09-19-17, place of manufacture: brandywine plant.Part expiration date: n/a (non-sterile).Device history batch null, device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, which would contribute to this complaint condition.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.
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.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.

• Brand Name: MAXFRAME(TM) FULL RING 150MM ALUMINUM
• 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: 8261151
• Report Number: 2939274-2019-55924
• Device Sequence Number: 183720
• Product Code: KTT
• UDI-Device Identifier: 10886982260819
• UDI-Public: (01)10886982260819
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K161417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.312.150
• Device Catalogue Number: 03.312.150
• Device Lot Number: H420922
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 02/05/2019; 02/14/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/12/2019; 02/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention