MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING HEAD SCREW SELF-DRILLING 26MM; SCREW,FIXATION,BONE

Catalog Number 413.426S

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 history lot: part # 413.426s, lot # 95p7255, manufacturing site: (b)(4), release to warehouse date: 01.04.2021, expiry date: 01.03.2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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 had infection after a tomofix surgery.It was unknown if there is any schedule for further procedure.The patient has consequences are reported.This complaint involves ten(10) devices.This report is for (1) 5.0mm ti locking head screw self-drilling 26mm.This report is 10 of 10 for (b)(4).

• Brand Name: 5.0MM TI LOCKING HEAD SCREW SELF-DRILLING 26MM
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13129914
• MDR Text Key: 285333804
• Report Number: 8030965-2021-10626
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819283053
• UDI-Public: (01)07611819283053
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K023941
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 413.426S
• Device Lot Number: 95P7255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CORTSCR Ø4.5 SELF-TAP L50 TI; LOCKSCR Ø5 SELF-DRILL L26 TAN; LOCKSCR Ø5 SELF-DRILL L26 TAN; LOCKSCR Ø5 SELF-TAP L48 TAN; LOCKSCR Ø5 SELF-TAP L60 TAN; LOCKSCR Ø5 SELF-TAP L70 TAN; LOCKSCR Ø5 SELF-TAP L80 TAN; LOCKSCR Ø5 SELF-TAP L90 TAN; TOMOFIXTIBHEADPL MED PROX 4HO TI
• Patient Outcome(s): Required Intervention