MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW . STARDRIVE 16MM STERILE; PLATE,FIXATION,BONE

Catalog Number 04.210.116TS

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product code hwc.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient was treated for a secondary disassociated distal radius extension fracture due to fracture wasn't fixated as planned.It is unknown how the issue was discovered.It is unknown if there was a patient consequence.This complaint involves ten (10) devices.This report is for (1).2.4mm ti va locking screw stardrive 16mm sterile.This is report 5 of 10 for (b)(4).Related product complaint: (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.B4: alert date should be 8/13/2020, not 9/14/2020.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.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

Update: no additional revision surgery was performed due to the event.

Event Description

Update: the initial surgery occurred (b)(6) 2020.

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 investigation summary 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 history part: 04.210.116ts, lot: 6l87105, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 21 apr 2020, expiry date: 01 apr 2025.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part number: 04.210.116, lot number: 43p2152, manufacturing site: monument, release to warehouse date:06 march 2020.Part #: 04.210.116, synthes lot number: 43p2152, supplier lot #: 43p2152, release to warehouse date: 10-feb-2020, supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 LOCKING SCREW . STARDRIVE 16MM STERILE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10576943
• MDR Text Key: 208308080
• Report Number: 8030965-2020-07375
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07612334104113
• UDI-Public: (01)07612334104113
• Combination Product (y/n): N
• PMA/PMN Number: K103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.210.116TS
• Device Lot Number: 6L87105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Patient Sequence Number: 1
• Treatment: CORTSCR Ø2.4 SELF-TAP L14 TAN; CORTSCR Ø2.4 SELF-TAP L16 TAN; VA LOCKSCR Ø2.4 SELF-TAP L12 TAN; VA LOCKSCR Ø2.4 SELF-TAP L14 TAN; VA LOCKSCR Ø2.4 SELF-TAP L18 TAN; VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 3H
• Patient Outcome(s): Required Intervention