MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 4H/RIGHT/86MM; PLATE,FIXATION,BONE

Catalog Number 04.112.138

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Additional procode: hwc.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.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 underwent revision surgery due to hypersensitivity.The original ankle fracture surgery was performed a year prior.The surgeon reported the patient experienced hypersensitivity and possible metallosis where the plate was placed postoperatively.The implant was extracted successfully and no metallosis was observed.There was no surgical delay.The procedure was successfully completed.This report is for one (1) 2.7mm/3.5mm ti lcp lat distal fibula plate 4h/right/86mm.This is report 1 of 4 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.H3, h4, h6- the device was not returned.A photo-investigation was performed on the images ¿.Upon inspecting the images provided, there was no issues were observed with the plate since the quality of the images were not clear, so the complaint condition could not be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition could not be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot : part # 04.112.138 , lot # 24p9080 , manufacturing site: selzach, release to warehouse date: 11 nov2019, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 4H/RIGHT/86MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12392574
• MDR Text Key: 268964317
• Report Number: 8030965-2021-07373
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819382787
• UDI-Public: (01)07611819382787
• Combination Product (y/n): N
• PMA/PMN Number: K083213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.112.138
• Device Lot Number: 24P9080
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/02/2021
• Patient Sequence Number: 1
• Treatment: CORTEX SCREW Ø 3.5 MM, SELF-TAPPING, LEN; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L16 TI; CORTEX SCREW Ø 3.5 MM, SELF-TAPPING, LEN; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L16 TI
• Patient Outcome(s): Required Intervention