MAUDE Adverse Event Report: SYNTHES GMBH 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.010.076
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent an unknown surgery with recon locking for the femur.Two trocar combinations were inserted into the nail¿s screw hole.Then, two guide wires were inserted into the screw hole.During drilling, the drill has come off the screw hole and advanced.The trocar combination was pulled in and out several times to correct the orientation of the drill.The trocar combination was inserted into anterior cortical bone forcefully.After inserting two hip screws and one transverse locking screw, reduction was required.Therefore, the three screws and the nail were removed.Then, reduction was performed, and the nail was re-inserted.When the two trocar combinations were inserted into the aiming arm, one of the trocar combinations did not pass through the aiming arm.The surgeon determined that insertion of two trocar combinations at the same time was not possible.As a result, only one normal trocar combination was inserted.The surgery was completed successfully within 30 minutes delay.No further information is available.This report is for one (1) drillsl 8.5/3.2 f/03.010.075.This is report 1 of 6 for complaint (b)(4).
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.Additional narrative: device available for evaluation: 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.
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: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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: h3, h4, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the drillsl 8.5/3.2 f/03.010.075 had the shaft slightly bent.A dimensional inspection for the drillsl 8.5/3.2 f/03.010.075 was performed with gauge pins, only a 3.38mm pin was able to pass through the shaft.A functional test was performed, the trocar was inserted into the drill sleeve, and the drill sleeve into the protection sleeve, it did not advance smoothly and the overall assembly was not successful, this issue most likely due to the bent condition of the drill sleeve and all of the mating devices.The complaint condition was able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the drillsl 8.5/3.2 f/03.010.075 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review part number: 03.010.076 lot number: 30p1610 manufacturing site: haegendorf release to warehouse date: 27.03.2020 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.B5: updated event description.D1: updated brand name.D10: date of concomitant therapy is january 19, 2023.
Event or Problem Description
The surgeon commented that there was no problem with bone fixation.

• Brand Name: 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16342354
• Report Number: 8030965-2023-01639
• Device Sequence Number: 20411970
• Product Code: FZX
• UDI-Device Identifier: 07611819765689
• UDI-Public: (01)07611819765689
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.076
• Device Lot Number: 30P1610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 03/10/2023; 03/27/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/21/2023; 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROTECT SLEEVE 11.5/8.5 F/LFN RECOLOCK; TROCAR Ø3.2 F/03.010.076; UNK - DRILL BITS: TRAUMA; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - SCREWS: TRAUMA
• Patient Sex: Unknown