MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7 TI VA-LCP 2-C DRP STD 6H HD/10H SHAFT/145MM/RT-STER; PLATE, FIXATION, BONE

Catalog Number	04.111.680S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
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.Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter 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.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
Device report from synthes reports an event in hong kong as follows: it was reported that on january 3, 2023, the va drill sleeve could not attach to the va screw holes.There were no patient consequences.No further information is available.This report involves one 2.4/2.7 ti va-lcp 2-c drp std 6h hd/10h shaft/145mm/rt-ster.This is report 1 of 2 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.Part number: 04.111.680s, lot number: 172p907, manufacturing site: mezzovico, release to warehouse date: 22 jun 2021, expiration date: 1 jun 2031.A manufacturing record evaluation was performed for the sterile lot number, and no nonconformances 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 there were no damage or defect with the va-lcp-2col dist-rad-pl2.4/2.7 x-long st.A dimensional inspection was performed for the va-lcp-2col dist-rad-pl2.4/2.7 x-long stand and met specifications for all three screw hole type sections.Locking screw, threaded guidewire and flat section of the combi-hole.A functional test was unable to be performed due to device was received itself.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the va-lcp-2col dist-rad-pl2.4/2.7 x-long st would not 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.Drawing/specifications reviewed: the following source controlled drawings reflecting the current and manufactured revisions were reviewed: -va-tcp, xl, std 6h, l145 10h (current and manufactured).Dimensional inspection: drawing: se_648872 rev.D, feature: hole diameter.Measured dimension: section d (conforming) section b-b (conforming) section f-f (conforming).Device used: vermont gage cd79318 gage pins vermont gage cd80413 gage pin.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: 2.4/2.7 TI VA-LCP 2-C DRP STD 6H HD/10H SHAFT/145MM/RT-STER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MEZZOVICO; via cavazz 5; mezzovico CO 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16245474
• Report Number: 8030965-2023-00952
• Device Sequence Number: 20471250
• Product Code: HRS
• UDI-Device Identifier: 07612334110817
• UDI-Public: 07612334110817
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K163046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.111.680S
• Device Lot Number: 172P907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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: UNK - GUIDES/SLEEVES/AIMING: SLEEVE
• Patient Sex: Unknown