MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LCP PROXIMAL TIBIA PL LOW BEND 4H/76MM/RIGHT-STER; PLATE, FIXATION, BONE

Catalog Number 04.124.200S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part: 04.124.200s lot: 8l22926 manufacturing site: (b)(4) supplier: (b)(4) release to warehouse date: 08 june 2021 expiration date: 01 may 2031 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part: 04.124.200 lot: 157p964 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2011, the patient underwent the open reduction internal fixation surgery for the tibial plateau fracture with the locking screw and the plate.During the surgery, when the surgeon tried to insert the locking screw into the most distal locking hole of the plate, the screw head penetrated the screw hole.At the judgement of the surgeon, the screw was left in the patient's body.The surgery was completed successfully within thirty (30) minutes delay.The patient is stable, so there are no plans for revision surgery at this point.No further information is available.This report is for one (1) 3.5mm ti lcp proximal tibia pl low bend 4h/76mm/right-ster this is report 2 of 2 for complaint (b)(4).

• Brand Name: 3.5MM TI LCP PROXIMAL TIBIA PL LOW BEND 4H/76MM/RIGHT-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12556337
• MDR Text Key: 281205768
• Report Number: 8030965-2021-08178
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819458567
• UDI-Public: (01)07611819458567
• Combination Product (y/n): N
• PMA/PMN Number: K030597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.124.200S
• Device Lot Number: 8L22926
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø3.5 SELF-TAP L28 TAN; UNK SCREWDRIVER
• Patient Age: 15 YR