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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH REAMER HEAD F/RIA 2 10
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SYNTHES GMBH REAMER HEAD F/RIA 2 10 Back to Search Results
Catalog Number 03.404.016S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 09/15/2020
Event Type  Injury  
Manufacturer Narrative
Additional device product codes: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during an ria 2 operation for bone removal of the femur, the drill head came loose from the ria system in the middle of the shaft.The patient had above average hard bone and a narrow medullary canal.There were issues inserting the synream drill wire and during reaming the drill head came loose.The drill head was removed with the synream drill wire.The reamer head spring clips had broken off and one (1) small piece remains in the femur.The operation continued with an 11mm drill head.The procedure was completed successfully.There was a surgical delay of thirty (30) minutes.There was no reported consequence to the patient.Concomitant devices reported: synream drill wire (part number unknown, lot unknown, quantity 1), ria 2 (part number unknown, lot unknown, quantity 1), flexible shaft (part unknown, lot unknown, quantity 1).This report involves one (1) 10.0mm reamer head for ria 2 sterile.This is report 1 of 1 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.H6: part number:03.404.016s, synthes lot number: 51p1094, supplier lot number: n/a, release to warehouse date: 27mar2020, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Picture review: narrative (broken off part and embedded device) could be confirmed from provided x-ray.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventive 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.
 
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- all four (4) prongs of the ria 2 reamer head are broken off.The fragments with the part and lot number etching were not returned for evaluation.Otherwise is the reamer head in a good condition with no visible damages at the cutting edges.The complaint is confirmed as all prongs of the reamer head are broken off, the embedded fragment can also be confirmed on the received x-ray.During the performed evaluation no manufacturing related issue could be detected.It can only be assumed that a mechanical overload related to the mentioned combination between above-average hard bone and very narrow medullary canal did contribute to the breakage of this device.Related to this breakage it can be mentioned that there was a trend with broken ria 2 reamer heads identified during our post market surveillance, therefore our product development center decided to open a capa for a deeper root cause analysis also a product issue escalation was initiated to define further actions related to these breakages.Due to these open activities the remaining investigation steps of this complaint investigation were not conducted.Device history lot part number:03.404.016s, synthes lot number: 51p1094, supplier lot number: n/a, release to warehouse date: 27mar2020, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.,see picture review pi-(b)(4).Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.,null.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
REAMER HEAD F/RIA 2 10
Type of Device
REAMER
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10609289
MDR Text Key209341988
Report Number8030965-2020-07566
Device Sequence Number1
Product Code HTO
UDI-Device Identifier07612334142382
UDI-Public(01)07612334142382
Combination Product (y/n)N
PMA/PMN Number
K111437
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 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.404.016S
Device Lot Number51P1094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2020
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK - FLEXIBLE SHAFTS; UNK - RIA; UNK - SYNREAM DRILL WIRE
Patient Outcome(s) Required Intervention;
Patient Age44 YR
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