MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 7.3MM CANNULATED LOCKING SCREW 140MM; PIN, FIXATION, THREADED

Catalog Number 02.207.140S

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 # 02.207.140s sterile lot # l016201 release to warehouse date: 31 may 2016 expiration date: 01 may 2026 supplier: (b)(4).Non-sterile: part # 02.207.140 lot # h047640 release to warehouse date: 15 mar 2016 manufactured by synthes (b)(4) no ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 has 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 eight (8) devices.This report is for (1) 7.3mm cannulated locking screw 140mm.This report is 2 of 8 for (b)(4).

• Brand Name: 7.3MM CANNULATED LOCKING SCREW 140MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13125829
• MDR Text Key: 286998211
• Report Number: 8030965-2021-10594
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07611819902787
• UDI-Public: (01)07611819902787
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K040765
• 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: 12/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.207.140S
• Device Lot Number: L016201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 SELF-DRILL L26 TAN.; LOCKSCR Ø5 SELF-TAP L40 TAN.; LOCKSCR Ø5 SELF-TAP L50 TAN.; LOCKSCR Ø5 SELF-TAP L55 TAN.; LOCKSCR Ø5 SELF-TAP L75 TAN.; LOCKSCR Ø5 SELF-TAP L75 TAN.; TOMOFIXTIBHEADPL MED PROX 4HO TI.
• Patient Outcome(s): Required Intervention