MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC GUIDEWIRE 1.25 W/THREAD-TIP W/TROCAR L1; WIRE, SURGICAL

Catalog Number 292.620S

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 (b)(6) reports an event as follows: it was reported on (b)(6) 2020, the patient underwent for an unknown surgery.During the surgery, when threaded pin inserting in cannulated screw, the pin was break off and leaving a part inside the patient¿s bone.The surgery was completed successfully with 20 minutes delay.There were no patient consequences reported.Concomitant device reported: unknown cannulated screw (part#: unknown, lot#: unknown, quantity: 1); unknown drill (part#: unknown, lot#: unknown, quantity: 1).This complaint involves one (1) device.This report is for (1) depth gauge for small screws.This report is 1 of 1 for (b)(4).

• Brand Name: GUIDEWIRE 1.25 W/THREAD-TIP W/TROCAR L1
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11020850
• MDR Text Key: 221801368
• Report Number: 2939274-2020-05613
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819733121
• UDI-Public: (01)07611819733121
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 292.620S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - DRILL; UNK - SCREWS: CANNULATED
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR