MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA-LCP VOLAR RIM DSTL RAD PL/7H HD/5H SHFT/LT-STER; PLATE, FIXATION, BONE

Catalog Number 04.115.851S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is company representative.Without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the surgery for distal radius fractures using 2.4 mm variable angle (va) lcp volar rim distal radius plate and screws.During the surgery, the surgeon could not achieve the torque for a va locking screw at the second hole of the plate at the radial side.This va locking screw was inserted using a drill sleeve at 5-degree angle in order to grasp the volar lunate facet fragment.Although no damages was found on the thread part of this va locking screw, the surgeon replaced this va locking screw with another one, but torque was not achieved with this va locking screw.The surgeon decided to close the incision without inserting a va locking screw in this hole.The surgery was completed successfully with all screws other than this va locking screw inserted with a proper torque.Concomitant device reported: va-lcp drill sleeve 2.4 f/drill bit ø1.8 (part# 03.110.000; lot# unknown; quantity: unknown).This is report 1 of 3 for (b)(4).

Event Description

The screw hall of the plate may have been damaged by drill.There were no issues with bone fixation.

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.H3, h4, h6: part number: 04.115.851s, lot number: 43p6464, manufacturing site: mezzovico, release to warehouse date: 10 march 2020, expiry date: 01 march 2030.A manufacturing record evaluation was performed and no non-conformances were identified.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 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.

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.H10 additional narrative: d4: expiration date updated g1: physical manufacturer updated h4: manufacture date updated 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: 2.4MM TI VA-LCP VOLAR RIM DSTL RAD PL/7H HD/5H SHFT/LT-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10157523
• MDR Text Key: 195246163
• Report Number: 8030965-2020-04187
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819461475
• UDI-Public: (01)07611819461475
• Combination Product (y/n): N
• PMA/PMN Number: K110125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.115.851S
• Device Lot Number: 43P6464
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Patient Sequence Number: 1
• Treatment: VA LOCKSCR Ø2.4 SELF-TAP L14 TAN; VA LOCKSCR Ø2.4 SELF-TAP L14 TAN; VA-LCP DRILL SLEEVE 2.4 F/DRILL BIT Ø1.8; VA LOCKSCR Ø2.4 SELF-TAP L14 TAN.; VA LOCKSCR Ø2.4 SELF-TAP L14 TAN.; VA-LCP DRILL SLEEVE 2.4 F/DRILL BIT Ø1.8.