MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147MM/LEFT; PLATE, FIXATION, BONE

Model Number	02.127.231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, a patient underwent a procedure to treat the distal tibia and fibula fracture with a tibia nail and fibula plate.The patient had zero healing properties and consequently, the patients distal leg was quite rotting off.On (b)(6) 2021 the tibia nail along with five (5) 5.0mm locking screws were removed and patient's leg was amputated below the knee.Clinical outcome experienced by the patient was infection.No further information provided.This report is for one (1) 3.5mm va-lcp prox tibia plate small bend/8h/147mm/left.This is report 7 of 7 for complaint (b)(4).
Additional Manufacturer Narrative
Event year is 2021; however exact date of post-operative infection development is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: g1 - manufacturing site name and address.H4 - device manufacture date.H6 - codes updated to imdrf codes.Investigation summary: the complaint device was not received for investigation.An investigation was performed based on the image attached to the pc titled ¿(b)(4)¿.The image was reviewed, and the complaint condition cannot be confirmed.There are minor surface scratches on the device, likely from the explant procedure.There is no other damage visible on the device.A definitive assignable root cause could not be determined based on the provided information.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 during the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - part: 02.127.231-us.Lot: 21p6865.Manufacturing site: raron.Release to warehouse date: 17.Oct.2019.A manufacturing record evaluation was performed for the finished device 02.127.231-us - lot: 21p6865.Non-conformances nr-0132987 was identified within labeling step (0130), but without any product impact.Nr-0132987 was a planned nr referenced to cut over activities (temporary disconnection between jabil erp and jnj erp which will prevent all synthes sites to follow procedure se_001023 verpackung synthes europe/synthes usa).This non-conformance has no impact to the product or impact any manufacturing irregularities.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: 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147MM/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron CO 3942 ; SZ 3942
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12779371
• Report Number: 8030965-2021-09397
• Device Sequence Number: 15351827
• Product Code: HRS
• UDI-Device Identifier: 10886982043566
• UDI-Public: (01)10886982043566
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: 02.127.231
• Device Catalogue Number: 02.127.231
• Device Lot Number: 21P6865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12 TI CANN TIB NAIL-EX PROX BEND 375-S; 5.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 46 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 56 FOR IM NAILS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male