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 Problem Device-Device Incompatibility (2919)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for the fracture of distal end of humerus (ao classification: 13a2).During the surgery, the surgeon tried to insert the locking screw in the most distal hole of the plate but could not lock because the locking screw idled in the plate hole.The surgeon once took out the plate from the patient body and checked it, but there were also other holes where the lock could not be performed, so the surgeon decided not to use this plate and the screws.The surgery was completed successfully using another 4-holes plate with a 20 minute delay.This report is for one (1) 2.7/3.5 ti va-lcp postlat dhp- lat supt 3h/lt/75mm-short-ste.This is report 1 of 4 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no defects were found with va-lcp dhp 2.7/3.5 dorso-lat w/supp-lat.The dimensional inspection was not performed due to the complex geometry of the plate.The functional test was performed to check the interaction/locking of screw with the plate and due to the stripped condition of the screw head it wasn't able to appropriately lock with the threads of the plate.The stripped condition of the screw caused the alleged complaint condition.Thus no issues were identified with the plate.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for va-lcp dhp 2.7/3.5 dorso-lat w/supp-lat.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 history lot part number: 04.117.103s, lot number: 204p029, manufacturing site: raron, release to warehouse: 23.June 2021.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12712468
• MDR Text Key: 278840646
• Report Number: 8030965-2021-09084
• Device Sequence Number: 1
• Product Code: HRS
• 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
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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: 204P029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA
• Patient Sex: Female