MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM VA-LCKNG SCREW SLF-TPNG WITH T6 STARDRIVE RECESS 16MM; PLATE,FIXATION,BONE

Catalog Number 02.130.316

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j sales representative.Without a lot number, the device history records review could not be completed as no product was received.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient underwent for a revision surgery on (b)(6) 2021 due to long screws in third metacarpal left hand, hematoma in surgical wound.During the surgery, surgical wound sutures are removed, the hematoma is drained, the wound is washed, and the third metacarpal is exposed.Osteosynthesis material is exposed, two screws are removed, osteosynthesis is made with two locked screws, one 16 mm and the other 12 mm.It is washed again, hemostasis, the wound is sutured, it is covered with sterile dressings and bandages, a plaster splint is placed again.The surgery was completed successfully.There was no consequence to the patient.This complaint involves (3) devices.This report is for (1) 2.0mm va-lckng screw slf-tpng with t6 stardrive recess 16mm.This report is 1 of 3 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.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: 2.0MM VA-LCKNG SCREW SLF-TPNG WITH T6 STARDRIVE RECESS 16MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12241288
• MDR Text Key: 266623849
• Report Number: 8030965-2021-06131
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819689169
• UDI-Public: (01)07611819689169
• Combination Product (y/n): N
• PMA/PMN Number: K150099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.130.316
• Device Lot Number: L423464
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: VA LOCKING HAND SYSTEM; VA LOCKSCR Ø2 SELF-TAP L12 SST
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR