MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/10 HOLE/230MM/LEFT; PLATE, FIXATION, BONE

Model Number	04.124.411
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in spain as follows: it was reported that on an unknown date, the implant ruptured and the patient needed reoperation.This report involves one (1) 4.5mm ti va-lcp crvd condylar plate/10 hole/230mm/left.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Procode additional device product codes: hwc and jdp.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Report occupation: reporter is a j&j employee.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.
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.D9, g3: device returned 20-july-2022 g6: follow up #1 h2, h3, h6: device evaluated product code : 04.124.411 lot number : 63p9848 manufacturing site: (b)(4) release to warehouse date:12 aug 2020 a manufacturing record evaluation was performed for the not-sterile lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that va-lcp condylar plate 4.5/5.0 le 10ho l2 was has broken in two pieces.The broken pieces were returned.Additionally, a position-pin 4.5 f/lcp ti was found, embedded in one of the sample holes.A dimensional inspection was performed for the va-lcp condylar plate 4.5/5.0 le 10ho l2 and met specifications.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the va-lcp condylar plate 4.5/5.0 le 10ho l2 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition 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 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: 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/10 HOLE/230MM/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES MEZZOVICO GMBH; via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14686138
• Report Number: 8030965-2022-03954
• Device Sequence Number: 11921057
• Product Code: HRS
• UDI-Device Identifier: 10886982110947
• UDI-Public: (01)10886982110947
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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 Model Number: 04.124.411
• Device Catalogue Number: 04.124.411
• Device Lot Number: 63P9848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 07/20/2022; 08/18/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 08/16/2022; 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female