MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE; BONE PLATE

Model Number	806.004.10S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.(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) 2020 the patient had a cranial vault reconstruction surgery.The patient was taken back to the on (b)(6) 2020 for removal of the affected plate.After the incision/exposure of the affected area it was determined that the plate that buckled was not the 1.5mm resorbable strut plate 2x36 holes (851.436.01s), but instead a 2.0mm resorbable strut plate 2x18 holes (852.421.01s) with 2.0mm resorbable cortex screws (8 ea) (806.004.10s).The gap in the bone that plate spanned was 15mm.The surgeon used a periosteal elevator to pry the plate off of the bone for removal and as a result he broke the plate in half and sheared the screws.Upon removal of the affected plate/screws the wound was debrided, irrigated, and closed.It is unknown if there was a surgical delay.The procedure and patient status is unknown.This report is for one 2.0mm rapid resorbable cortex screw 4mm-sterile.This is report 3 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.Visual inspection: the 2.0 mm rapid resorbable cortex screw 4mm-sterile (p/n:806.004.10s, lot #: 6l38740) was returned and received at us cq.Upon visual inspection, it was observed that the tip of the screw is broken but that is consistent with the design and explantation of the device.The broken fragment was not returned.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture, drawings are reflecting the current and manufactured revision were reviewed.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the 2.0 mm rapid resorbable cortex screw 4mm-sterile (p/n:806.004.10s, lot #: 6l38740).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that 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: 806.004.10s-us, lot: 6l38740 , manufacturing site: oberdorf, release to warehouse date: dec.13, 2019, expiry date: nov.30, 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.
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.H11: corrected data: g4: awareness date reported on follow up 1 report as february 26, 2020 but should have been march 31, 2020.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 CORTEX SCREW 4MM-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: 9744291
• Report Number: 2939274-2020-01009
• Device Sequence Number: 13946625
• Product Code: JEY
• UDI-Device Identifier: 20887587061839
• UDI-Public: (01)20887587061839
• 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: 2020
• Device Explanted Year: 2020
• 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): 02/01/2020

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: 11/30/2023
• Device Model Number: 806.004.10S
• Device Catalogue Number: 806.004.10S
• Device Lot Number: 6L38740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 02/26/2020; 04/03/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/01/2020; 04/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 MO