MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 1H/LT/72MM-SHORT-STER; PLATE, FIXATION, BONE

Catalog Number 04.117.701S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Initial reporter facility name: (b)(6).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) 2021, the patient underwent the open reduction internal fixation for transcondylar fracture of the distal left upper arm with the screw.When the surgeon tried to lock the plate with the screw, the screw did not lock at the second hole of the distal end of the plate.At the discretion of the surgeon, the screw that did not lock was left in the body, and the surgery was completed without any surgical delay.This report involves one (1) 2.7mm/3.5mm ti va-lcp ext medl dhp 1h/lt/72mm-short-ster.This is report 1 of 2 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 contributed to the potential event described in this report.H3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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.

• Brand Name: 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 1H/LT/72MM-SHORT-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11685875
• MDR Text Key: 248083341
• Report Number: 8030965-2021-03025
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819505698
• UDI-Public: (01)07611819505698
• Combination Product (y/n): N
• PMA/PMN Number: K120070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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: 04.117.701S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/19/2021
• Patient Sequence Number: 1
• Treatment: VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L52 TA