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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 12.0MM REAMER HEAD FOR RIA 2 STERILE
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OBERDORF SYNTHES PRODUKTIONS GMBH 12.0MM REAMER HEAD FOR RIA 2 STERILE Back to Search Results
Catalog Number 03.404.020S
Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative
Additional device product codes: hrx.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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 ii surgery the drill head loosened itself from the drilling shaft.The drilling head could be recovered with the 2,5mm drill mantel which was connected to the olive.The drilling head was reattached but came loose again and was recovered again.A new drill head with a diameter of 12mm was used after that which also loosened itself from the drilling shaft.On the x-ray it appeared that metal fragments had remained at the entrance of the medullary canal.There was a surgical delay of fifteen (15) minutes.Enough material could be harvested from the medullary cavity to complete the surgery successfully.Another piece detached from the drilling shaft end where the drill head is locked in place.The patient was reported as good after the procedure.Concomitant devices reported: reamer head f/ria 2 ø12.5 (part number 03.404.021s, lot 26p2108, quantity 1), drive shaft f/ria 2 l520 (part number 03.404.035, lot h860686, quantity 1).This report involves one (1) 12.0mm reamer head for ria 2 sterile.This is report 2 of 3 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.Investigation summary visual inspection: reamer head f/ria 2 ø12 (part.No: 03.404.020s, lot.No: 39p1189, qty: 1) was returned and received at us customer quality (cq).Upon visual inspection at cq, it is observed that the proximal tabs that connect to the harvesting tube were broken.The broken pieces were not returned at cq.It is observed in the x-rays provided that the broken pieces were embedded in the patient¿s body.Thus, the reported embedded condition is confirmed.Functional test: functional testing of the received device cannot be performed due to the broken condition.Can the complaint be replicated with the returned devices? unable to perform dimensional inspection: dimensional inspection of the relevant features of the returned device cannot be performed at cq due to post manufacturing damage.Document/specification review: the following drawings were reviewed during the investigation: -14.0mm reamer head ria 2 no design issues or discrepancies were noted during the investigation.Complaint confirmed? yes reported device interaction condition cannot be confirmed as the functional testing of the received device was unable to performed at cq.Investigation conclusion: the complaint could be confirmed for reamer head f/ria 2 ø12 (part.No: 03.404.020s, lot.No: 39p1189).A definitive root cause for the reported problem could not be determined.It is possible that the device might have encountered unintended forces.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to 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.
 
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: investigation summary: product was not returned.Reviewing attached picture, metal fragments remained in patients bone could be confirmed.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 history lot: part # 03.404.020s, synthes lot # 39p1189, supplier lot # na, release to warehouse date: feb 05, 2020 , expiration date: jan 01, 2030, manufactured by jabil monument , no ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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
12.0MM REAMER HEAD FOR RIA 2 STERILE
Type of Device
REAMER
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10397558
MDR Text Key203693186
Report Number8030965-2020-05907
Device Sequence Number1
Product Code HTO
UDI-Device Identifier07612334142429
UDI-Public(01)07612334142429
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 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.404.020S
Device Lot Number39P1189
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Date Manufacturer Received09/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DRIVE SHAFT F/RIA 2 L520; REAMER HEAD F/RIA 2 Ø12.5
Patient Outcome(s) Required Intervention;
Patient Age48 YR
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