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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM CANNULATED DRILL BIT/QC 150MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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SYNTHES GMBH 2.0MM CANNULATED DRILL BIT/QC 150MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 310.221
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/06/2021
Event Type  Injury  
Manufacturer Narrative
Reporter facility name: (b)(6) medical center.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(b)(4).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 on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for a foot navicular bone fracture with the guide wire and drill bit.During the surgery, the guide wire broke because the bone quality was very good.The surgeon used the drill bit to remove the fragment of the guide wire, but the drill bit broke.The surgeon tried to remove the fragments, but some fragments remained in the patient.The surgery was completed with fifty (50) minute surgical delay.The revision surgery has not been scheduled.Concomitant devices reported: guidewire ø1.1 l150 sst (part number 292.623s, lot 60p5509, quantity 1).This report involves one (1) 2.0mm cannulated drill bit/qc 150mm.This is report 2 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.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.H3, h4, h6- the tips of the cannulated drill bits are completely broken off as complained.A part of circa 4mm at the tips is broken off.It was only three broken parts / fragment returned for investigation.Besides, the instruments presents normal signs of use.Dimensions were checked and found to comply with the specifications.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, material and visual criteria at the time of release with no issues documented during the manufacturing process.As part of depuy synthes¿ quality process all devices are manufactured, inspected, and released to approved specifications.The complaint condition is confirmed as the tips of the drill bits are broken off.This production lot conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The correct material was used, and the hardness parameters were within the specifications.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be postproduction/acceptance criterias.A definitive root cause for the drill bit breaking could not be determined based on the provided information.However, we do suppose that the device encountered unintended forces, such as excessive force application during its use, which finally resulted in the breakage.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance device history lot : part: 310.221, lot: f-29903, manufacturing site: selzach, supplier: (b)(4).Release to warehouse date: 25 may 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance related to the reported complaint condition 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.
 
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Brand Name
2.0MM CANNULATED DRILL BIT/QC 150MM
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11244347
MDR Text Key229151513
Report Number8030965-2021-00698
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07611819086074
UDI-Public(01)07611819086074
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 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number310.221
Device Lot NumberF-29903
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2021
Date Manufacturer Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE Ø1.1 L150 SST; GUIDEWIRE Ø1.1 L150 SST
Patient Outcome(s) Required Intervention;
Patient Age14 YR
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