MAUDE Adverse Event Report: SYNTHES GMBH 1.6MM KIRSCHNER WIRE W/TROCAR POINT 285MM; WIRE, SURGICAL

Catalog Number 292.180.01

Device Problems Material Deformation (2976); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 a procedure on (b)(6) 2021 one (1) 3.5mm philos long 12-hole plate was scratched since the beginning of the surgery.One (1) 3.5mm ti philos 3 hole plate was scratched.Two (2) 1.6mm k-wire were scratched or bent and one (1) 2.0mm k-wire was worn.The procedure was successfully completed without any surgical delay.The patient outcome is reported as successful.This report is for one (1) 1.6mm kirschner wire w/trocar point 285mm.This is report 3 of 3 for complaint (b)(4).

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: h3, h4, h6: product code: 292.180.01 lot #: 60p5498 manufacturing site: balsthal release to warehouse date: july 2, 2020 a manufacturing record evaluation was performed for the finished device 292.180.01 lot number 60p5498, and no non-conformances were identified.Product was not returned.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 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: 1.6MM KIRSCHNER WIRE W/TROCAR POINT 285MM
• 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: 12501796
• MDR Text Key: 272482474
• Report Number: 8030965-2021-07884
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819319721
• UDI-Public: (01)07611819319721
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.180.01
• Device Lot Number: 60P5498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female