MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILE; BONE PLATE

Model Number	852.421.01S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.(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 the patient had frontal orbital advancement surgery using four (4) 2.0 mm rapid resorbable strut plates and nine (9) packages of 2.0 mm rapid resorbable cortex screws.Between (b)(6) the plates on the lateral aspects of the advancement buckled, they did not break.The patient was brought back to the operating room on (b)(6) 2019 for the removal of the lateral plates/ screws and re-plating.It is unknown if there was surgical delay.The procedure and patient outcomes were good.Concomitant devices: 2.0 mm rapid resorbable cortex screw 4 mm-sterile (part 806.004.04s, lot 5l87602, quantity 9).This report is for one 2.0 mm rapid resorbable strut plate 2 holesx18 holes-sterile.This is report 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.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 had frontal orbital advancement surgery on (b)(6) 2019, and the surgeon used four (4) each of the 2.0mm rapid resorbable strut plate and a total of nine (9) packages of 2.0mm rapid resorbable cortex screw.On november seventeen to eighteen the plates on the lateral aspects of the advancement buckled, they did not break.The patient was brought back to the operating room on (b)(6) 2019, for removal of the lateral plates/screws and re-plating.It is unknown if there was surgical delay.The procedure and patient outcomes were good.Concomitant devices reported: 2.0mm rapid resorbable cortex screw 4mm-sterile (part# 806.004.04s, lot# unknown, quantity# 1).This is report 2 of 3 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.H3, h4, h6: 2.0mm rapid resorbable strut plate 2 holesx18 holes-sterile was received at us cq.Upon visual inspection at cq, it is observed that the implant is severely bent at multiple locations.Thus, the reported bent condition is confirmed.But the reported migration condition cannot be confirmed with the available information.A broken unknown resorbable cortex screw was returned lodged in the plate.It will be considered as another impacted product and will be investigated under another pi in the same complaint.A visual inspection, dimensional inspection, and document/ specification review were performed as part of this investigation.The complaint can be confirmed as the plate was found to be severely bent at multiple locations.While a definitive root cause could not be determined, it is possible that the implant might have encountered unintended forces.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 852.421.01s, lot: 5l93358, manufacturing site: oberdorf, release to warehouse date: 10.Oct.2019, expiry date: 31.Aug.2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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: 2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILE
• 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: 9467652
• Report Number: 2939274-2019-62661
• Device Sequence Number: 19359665
• Product Code: JEY
• UDI-Device Identifier: 10887587064352
• UDI-Public: (01)10887587064352
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K062789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/21/2019

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 Expiration Date: 08/31/2023
• Device Model Number: 852.421.01S
• Device Catalogue Number: 852.421.01S
• Device Lot Number: 5L93358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/08/2020; 01/08/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/09/2020; 01/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 MO