MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Catalog Number 04.005.520S

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

Patient Problems Unspecified Infection (1930); Inflammation (1932)

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 depuy synthes reports an event in italy as follows: it was reported that a patient had an original surgery due to biosseous fracture exposed at right leg on (b)(6) 2019.Postoperatively patient developed infection and inflammatory reaction from endomidollar nail, fistula third middle right leg.Patient needed a antibiotic therapy.No further information provided.This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 30mm f/im nail-ster.This is report 5 of 5 for complaint (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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 04.005.542, lot: l865336, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 17 apr 2018, expiration date: 01 apr 2028.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.005.542 non-sterile lot # l852616 manufacturing site: werk mezzovico release to warehouse date: 09 apr 2018 supplier: na.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15589432
• MDR Text Key: 301598555
• Report Number: 8030965-2022-08100
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819789784
• UDI-Public: (01)07611819789784
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.520S
• Device Lot Number: L865336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EXPERT TIBIAL NAIL PROTECT Ø10 CANN L345; LOCKSCR Ø5 L40 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L42 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L52 F/NAILS TAN LIGHT GREEN
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR