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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 4.3MM DRILL BIT LENGTH 413MM; BIT MILLING STERILE AND NON
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SYNTHES GMBH 4.3MM DRILL BIT LENGTH 413MM; BIT MILLING STERILE AND NON Back to Search Results
Catalog Number 03.168.011
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot: part: 03.168.011, lot: f-27502, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: july 31, 2019.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.
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6), 2020, the patient underwent the open reduction internal fixation surgery for the femoral neck medial fracture with the drill bit and sleeve in question.During the screw insertion, the surgeon tried to assemble the drill bit to the sleeve, but when the drill bit was inserted to the sleeve halfway, he couldn't push and pull the drill bit and it stuck to the sleeve.The surgeon removed the devices and implants once, and he could dissemble the drill bit from the sleeve.The surgeon tried to assemble them again out of the body, but he couldn't, too.The surgeon continued the surgery without using the drill bit and sleeve and the surgery was completed successfully.After the surgery when the surgeon tried to pass the drill bit through the sleeve, he had difficulty in assembling them, but he could pass the drill bit through the sleeve.No further information is available.Concomitant device reported: unknown screw (part#: unknown, lot#: unknown, quantity: 1).This complaint involves two devices.This report is for (1) drill bit ø4.3 l413.This report is 1 of 2 for (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.H3, h6: part: 03.168.011, lot: f-27502, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: july 31, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.Depuy synthes then conducted visual and functional inspection of the returned device.Visual analysis of the returned drill bit determined that the device is in a very used condition.There are strong stress marks at the shaft visible and the cutting edges are completely blunt.A functional test with the also received sleeve was performed; the drill bit could be inserted and removed without any issues.It was not possible to reproduce the complained malfunction.Nevertheless, the complaint is rated as confirmed as the visual damages at the shaft indicate that there was an issue during the procedure.This issue was clearly caused by a deformation at the sleeve and not by any malfunction of the drill bit.Next to that, it can be stated that the drill bit is in a end of life condition as the cutting edges are completely worn.As part of depuy synthes quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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.
 
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: d7 h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.D1, d2, d10.
 
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Brand Name
4.3MM DRILL BIT LENGTH 413MM
Type of Device
BIT MILLING STERILE AND NON
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11023225
MDR Text Key245681437
Report Number8030965-2020-09810
Device Sequence Number1
Product Code GFG
UDI-Device Identifier07611819657373
UDI-Public(01)07611819657373
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.168.011
Device Lot NumberF-27502
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Date Manufacturer Received02/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PROTECTION SLEEVE F/INSERTION INSTR; UNK - SCREWS: TRAUMA
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