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

Catalog Number 852.421.01S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 11/01/2019

Event Type  Injury  

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 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 1 of 2 for (b)(4).

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 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 (b)(6) to (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 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 1 of 3 for (b)(4).

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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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 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
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9467598
• MDR Text Key: 170732872
• Report Number: 2939274-2019-62660
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K062789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• 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 Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 12/13/2019; 01/08/2020; 01/08/2020
• Supplement Dates FDA Received: 12/13/2019; 01/09/2020; 01/10/2020
• Patient Sequence Number: 1
• Treatment: 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE; 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
• Patient Outcome(s): Required Intervention
• Patient Age: 29 MO