MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM THREADED GUIDE WIRE 230MM; WIRE, SURGICAL

Model Number	292.65
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is against user facility medwatch number mw5118357, a copy is attached.The only information contained in this report is correction or additional information.
Additional 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.H10 additional narrative: reported by user: b3, b5, d1, d2a, d2b, d6a d7a, d9, h1.Reported by manufacturer: d4: udi added.E1: country added; no facility information is available.E3: initial reporter already reported to the fda.G1: manufacturer information added.H3: device not returned to manufacturer.H5: device labeled for single use.H6: health effect clinical code updated.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.Corrected data: d1: device name updated.D2b: additional device product codes: jdw.D6a: not applicable.D7a: unknown if device was re-processed.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.Unknown.

• Brand Name: 2.0MM THREADED GUIDE WIRE 230MM
• Common Device Name: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17306861
• Report Number: 8030965-2023-08653
• Device Sequence Number: 20636512
• Product Code: LRN
• UDI-Device Identifier: 10886982180742
• UDI-Public: (01)10886982180742
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 292.65
• Device Catalogue Number: 292.65
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown