MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM UNIVERSAL DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number 323.26

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Type  malfunction  

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: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.H3, h6: 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

It was reported on an unknown date that some items were removed from a modular mini-fragment and needed to be replaced.2.0 and 2.4/2.7 bending irons are bleeding a rust-looking substance from the lettering printed.The drill guide cannot separate the inserts to disassemble because the threaded tip won¿t slide over the insert.The depth gauge tip is bent.The 2.7-module side is broken.There was no patient involvement, and no adverse events occurred.This report is for one (1)2.7mm universal drill guide.This is report 2 of 2 for complaint.

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.The customer reported that the 323.26, 2.7mm universal drill guide cannot separate the inserts to disassemble because threaded tip won't slide over insert.The repair technician reported that the drill sleeve was bent.Damaged component is the reason for repair.The cause of the issue is unknown.The following part was replaced: 2.0 mm drill sleeve.The item was repaired per the inspection sheet, passed synthes final inspection on 18-september-2023 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.Part # 323.26.Lot # 1l01282.Manufacturing site: werk hagendorf.Release to warehouse date: 13 sep 2018.Expiration date: n/a.Supplier: n/a.A manufacturing record evaluation was performed for the finished article lot 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.

• Brand Name: 2.7MM UNIVERSAL DRILL GUIDE
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; im bifang 6; werk hagendorf; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17785367
• MDR Text Key: 323913934
• Report Number: 8030965-2023-11866
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 323.26
• Device Lot Number: 1L01282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.7MM LCP(TM) MODULE CASE; BEND-PIN F/LCP-PL 2; BEND-PIN F/LCP-PL 2; BEND-PIN F/LCP-PL 2.4+2.7; BEND-PIN F/LCP-PL 2.4+2.7; DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T