MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM TI COMPRESSION TENSION BAND PLATE 6 HOLES/36MM; BONE PLATE

Model Number	449.110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	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.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.(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 (b)(6) 2019, patient was implanted with a titanium compression tension band plate and six (6) titanium (ti) cortex screws.Approximately nine (9) days after implantation, the patient returned to the oral surgery office because their mandible felt displaced.It was discovered that the plate had broken.Concomitant devices: titanium cortex screw self-tapping (part: 401.506e, lot: unknown, quantity: 6).This report is for a 2.4mm ti compression tension band plate.This is report 1 of 1 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.Dhr review & material analysis: the design specified the plate to be manufactured from implant grade 4 titanium.A review of the device history records including material confirmation was unable to be performed since the lot number was unknown.Document/specification review: design drawing was reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.Part number: 449.110 , complaint category: broken- post op , product family: 2.4 mm titanium compression tension band plates (449.100-449.110).Investigation conclusion: a definitive assignable root cause for the plate breaking 9 days post op could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation and the dcrm adequately address the harm of this complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.Updated 28 march 2019 for investigation of provided x-ray image.(actual device was not returned) background: modified event description: it was reported that on (b)(6) 2019, patient was implanted with a titanium compression tension band plate and six (6) titanium (ti) cortex screws.Approximately nine (9) days after implantation, the patient returned to the oral surgery office because mandible felt displaced.It was discovered that the plate had broken.Procedure was successfully completed.Visual inspection: actual device was not returned.Visual inspection performed at customer quality (cq) of the complaint device in complaint file "(b)(4) additional information from sales consultant 18 mar 2019" confirmed the condition of post-operative plate breakage, which agrees with the reported complaint condition.The x-ray shows that the plate has broken transversely at the third hole from the left.No additional issues were identified.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: 2.4MM TI COMPRESSION TENSION BAND PLATE 6 HOLES/36MM
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8390160
• Report Number: 2939274-2019-56796
• Device Sequence Number: 1921574
• Product Code: JEY
• UDI-Device Identifier: 10887587054148
• UDI-Public: (01)10887587054148
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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: 449.110
• Device Catalogue Number: 449.110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 04/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention