MAUDE Adverse Event Report: SYNTHES GMBH RAPIDSORB CORTSCR 2 L4 2U; BONE PLATE

Catalog Number 806.004.02S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient went to see the surgeon as the screws had been exposed on the lesion.As far as the patient remembered, the screw exposure took place in (b)(6) 2021.On (b)(6) 2020 the patient underwent the primary orif procedure with rapidsorb system treating maxillary fracture.The patient is scheduled to undergo a revision procedure on (b)(6).No further information is available.This complaint involves unknown number of devices.This report is for (1) 2.0mm rapid resorbable cortex screw 4mm-sterile.This report is 2 of 7 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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.Device history lot part #: 806.004.02s, lot #: l855770, manufacturing site: werk bio oberdorf , release to warehouse date: jun 21, 2018.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: RAPIDSORB CORTSCR 2 L4 2U
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12356668
• MDR Text Key: 267830862
• Report Number: 8030965-2021-07080
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819748613
• UDI-Public: (01)07611819748613
• Combination Product (y/n): N
• PMA/PMN Number: K062789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 806.004.02S
• Device Lot Number: L855770
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: CMF; UNK - SCREWS: CMF; UNK - SCREWS: CMF
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Weight: 52