MAUDE Adverse Event Report: SYNTHES GMBH GUIDEWIRE 1.25 W/THREAD-TIP W/TROCAR L1; WIRE,SURGICAL

Catalog Number 292.62

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

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 synthes reports an event in (b)(6) as follows: it was reported that during an ankle surgery on an unknown date, the 1.25mm threaded guide wire broke in the patient.The broken wire was left in the patient.There was no surgical delay reported.No further information provided.This report is for one (1) 1.25mm threaded guide wire 150mm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Part: 292.620, lot: 75p1098, manufacturing site: (b)(4), release to warehouse date: november 10, 2020.A manufacturing record evaluation was performed for the finished device 292.620 lot number 75p1098 and no non-conformance were identified.Photo investigation: the device was not returned.A photo-investigation was performed on the image.Upon inspecting the x-ray/ photo provided, the guide wire was observed to be broken inside the patient.The reported embedded condition can be confirmed with the information provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/ specification review were not completed.Conclusion: the complaint condition can be confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/ or preventive action is proposed.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.

• Brand Name: GUIDEWIRE 1.25 W/THREAD-TIP W/TROCAR L1
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11496881
• MDR Text Key: 240373192
• Report Number: 8030965-2021-02033
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819013841
• UDI-Public: (01)07611819013841
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: PREAMENDMENT
• 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,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.62
• Device Lot Number: 75P1098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1