MAUDE Adverse Event Report: SYNTHES GMBH 2.7/3.5 TI VA-LCP POSTLAT DHP- LAT SUPT 3H/LT/75MM-SHORT-STE; PLATE, FIXATION, BONE

Catalog Number 04.117.103S

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

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: d2b: additional device product codes: hwc d9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter facility name: medical corporation inobukai kochi orthopedic and brain surgery hospital e3: reporter is a j&j employee.H3, h4, h6: 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 a manufacturing record evaluation was performed for the finished device (part # 04.117.103s lot # 4354p45) and no non-conformances / manufacturing irregularities 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.

Event Description

Device report from synthes reports an event in japan as follows: it was reported that during an open reduction/internal fixation surgery on (b)(6)2023, when the va lcp plate with lateral support was bended, the support part broke off.Another plate was used, and the surgery was completed successfully with no delay.This report involves one 2.7/3.5 ti va-lcp postlat dhp- lat supt 3h/lt/75mm-short-ste.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6 investigation summary 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 dhp 2.7/3.5 dorso-lat w/supp-lat was observed broken from the lateral support.The breakage condition can be attributed first to the bent condition that subsequently passed to break.No other issues were found.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection was not performed as it is not applicable to the complaint condition.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 dhp 2.7/3.5 dorso-lat w/supp-lat 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.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: n/a.Device history: a manufacturing record evaluation was performed for the finished device (part # 04.117.103s lot # 4354p45) and no non-conformances / manufacturing irregularities 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: 2.7/3.5 TI VA-LCP POSTLAT DHP- LAT SUPT 3H/LT/75MM-SHORT-STE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17372376
• MDR Text Key: 319789864
• Report Number: 8030965-2023-09105
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819505469
• UDI-Public: (01)07611819505469
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 04.117.103S
• Device Lot Number: 4354P45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1