MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Catalog Number 04.005.528S

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

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 available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility name: (b)(6) hospital.Initial reporter is a j&j employee.Part: 04.005.528s.Lot: 3l12119.Manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: 17 jan 2019.Expiration date: 01 jan 2029.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.005.528.Non-sterile lot # 2l89250.Manufacturing site: (b)(4).Release to warehouse date:03 jan 2019.Supplier: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 japan as follows: it was reported that the patient underwent open reduction/internal fixation surgery on (b)(6) 2021 with the tfna for a trochanteric fracture of the femur.In (b)(6) 2022, the patient fell, and a fracture occurred.In (b)(6) 2022, the patient complained of pain at the side of the lateral blade.On (b)(6) 2022, the patient underwent removal surgery due to pain.When the surgeon tried to attach extraction instruments to the blade, there was something like pus.Infection was suspected.This pc is related to (b)(4) which reports that the secondary fracture occurred due to fall after the surgery.This pc reports that infection was suspected during the removal surgery.This report involves one 5.0mm ti locking screw w/t25 stardrive 38mm f/im nail-ster.This is report 4 of 4 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15834326
• MDR Text Key: 304017610
• Report Number: 8030965-2022-10085
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.528S
• Device Lot Number: 3L12119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA END CAP EXTENS. 0 TAN.; TFNA FEM NAIL Ø10 LE 125° L235 TIMO15.; TFNA HELICAL BLADE PERF L100 TAN.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male