MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC TI LOCKING RECON PLATE 6 X 23 HOLES/44MM X 214MM-LEFT; BONE PLATE

Model Number	449.632
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of device breakage and non-union is not known.(b)(4) lot unknown.Date of implant reported as july 2017 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.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 a patient underwent a hardware removal and revision on (b)(6) 2017 of a mandibular modular locking plate that broke in vivo.The original procedure was performed in (b)(6) 2017.A non-union of a bone graft mandible was resected from the symphysis to the left angle; plate failure occurred at the osteotomy site of the left angle.Removed hardware included: one (1) broken plate and ten (10) screws.All explanted screws were intact and removed easily.No reported surgical delays or other untoward events.The patient was revised to a 2.8mm matrix plate and screws.Concomitant device report: 2.4mm anterior locking recon screws (part number unknown, lot number unknown, quantity 5), 2.4mm posterior locking recon screws (part number unknown, lot number unknown, quantity 5).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed for the subject device: one (1) titanium locking recon plate, 6 x 23 holes (part 449.632 | lot unknown| quantity 1) was reported with the complaint category of ¿broken (2+ pieces) postoperatively : rm.¿ however, the device was not returned for investigation; only an x-ray was provided.The provided x-ray in attachment ¿(b)(4) x-ray 12-28-17¿ was reviewed.The provided image shows a broken plate with five (5) screws in the anterior portion of the plate and five (5) screws in the posterior portion of the of the plate.The plate shows a roughly transverse break between the 13th and 14th hole from the anterior end.Based on the x-ray review, the complaint condition is confirmed and consistent with the reported condition.Replication is not applicable for this complaint condition of postoperative breakage.Furthermore, the device was not returned for evaluation.As the physical device was not received no further dimensional or material testing could be completed and the device could not be inspected to the drawing specification.A review of the device history record (dhr) could not be completed as the lot number is unknown.In conclusion, a visual inspection via the provided x-ray, complaint history review, and risk assessment review were performed as part of this investigation.The complaint condition is confirmed as the plate was observed to be broken in the x-ray.During the investigation no product issues were observed that may have contributed to the complaint condition.No definitive root cause was able to be determined as circumstances surrounding the event and the conditions during the unknown implant duration are unknown.Additionally, the device was not returned for inspection.The risk assessment was found to adequately address the complaint condition.No new malfunctions were observed during the course of this investigation.Unknown locking screws, lot # :unknown, quantity 10.These were reported as a concomitant devices without an alleged complaint condition.Upon visual inspection of the provided x-ray, there is no evidence that these devices contributed to the complaint condition, and therefore no additional investigation will be performed on these devices.Based on the information available, 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.

• Brand Name: TI LOCKING RECON PLATE 6 X 23 HOLES/44MM X 214MM-LEFT
• 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: 7088476
• Report Number: 2939274-2017-50171
• Device Sequence Number: 1798977
• Product Code: JEY
• UDI-Device Identifier: 10887587054483
• UDI-Public: (01)10887587054483(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K961421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: 449.632
• Device Catalogue Number: 449.632
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 85