MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø3.5 SELF-TAP L50 TAN; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 412.121S

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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), 2021, the patient underwent the open reduction internal fixation surgery using locking compression plate (lcp) distal tibia locking (dtl) plate for tibia.The surgery was completed successfully without any surgical delay.After the surgery, the removal surgery was performed due to unknown reason on (b)(6), 2022.In the surgery, it was confirmed that three screws in most distal area were broken.The screw breakage was not known before hand.The nurse commented that the screwdriver was forcefully hit with a hammer to fit all screw heads in the removal, which may have loaded the plate and screws and broken the screws.The procedure was to remove the screws in order from the proximal to the distal direction, and three screws on the distal side were found to be broken.Two (lot: 39p2545, 80p4257) of the three screws, including the broken pieces, could be removed, but one (lot: 39p2545) remained in the body.The surgery was completed with 3 hours delay.Initially planned operative time is 1 hour.This is report 3 of 4 for (b)(4).This report is for locking screw.

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: h3, h4, h6: part # 412.121s, lot # 39p2545, manufacturing site: jabil grenchen, release to warehouse date: 24.February.2020, expiry date: 01.February.2030.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Product was not returned.Based on the information available, it has been determined that no corrective and preventive 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: LOCKSCR Ø3.5 SELF-TAP L50 TAN
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14318187
• MDR Text Key: 291215668
• Report Number: 8030965-2022-03022
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819152182
• UDI-Public: (01)07611819152182
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412.121S
• Device Lot Number: 39P2545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LCP MED-DIST-TIBIAL PL 3.5 LOW BEND R 10; LOCKSCR Ø3.5 SELF-TAP L46 TAN; LOCKSCR Ø3.5 SELF-TAP L50 TAN; LOCKSCR Ø3.5 SELF-TAP L50 TAN; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK SCREWDRIVER
• Patient Outcome(s): Required Intervention