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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNKNOWN DRILL BITS; BIT, DRILL
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SYNTHES GMBH UNKNOWN DRILL BITS; BIT, DRILL Back to Search Results
Device Problems Break (1069); Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)
Event Date 02/29/2024
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).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: d1, d2, d3, d4, g4-510k: this report is for an unknown drill bits/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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 that on an unknown date, a broken drill left in the patients hip.This report is for one (1) unknown drill bits.This is report 1 of 1 for complaint (b)(4).
 
Event Description
The surgery was completed successfully with no delay.There is no plan for a revision surgery.
 
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.A1-a4: patient information added.B3: event date added.B5: event description updated.D4: udi, lot number, catalog code added.G4: 510k: exempt.H4: manufacture date added.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: brand name updated.D2a, d2b: procode, common device name updated h6: medical device problem codes updated.
 
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 number: 310.19-us, lot number: 3455p74, part manufacture date: 06-dec-2022, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.0mm drill bit/qc/100mm was processed through the normal manufacturing and inspection operations in elmira with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release from elmira with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 shaft of the 2.0mm drill bit/qc/100mm was broken, fragment was not received for evaluation.No x-ray evidence was received in order to confirm the embedded device allegation.No other issues were identified.A dimensional inspection for the 2.0mm drill bit/qc/100mm was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 2.0mm drill bit/qc/100mm would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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 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
UNKNOWN DRILL BITS
Type of Device
BIT, DRILL
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key18924597
MDR Text Key337912920
Report Number8030965-2024-03785
Device Sequence Number1
Product Code HTW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2022
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age51 YR
Patient SexMale
Patient Weight113 KG
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