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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0MM SCREWS
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SYNTHES GMBH HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0MM SCREWS Back to Search Results
Catalog Number 309.45
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/16/2021
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021, the patient underwent removal surgery of a femoral neck system (fns) nail and total hip arthroplasty.When the surgeon tried to remove a screw with the screwdriver which is other company¿s product, the screwdriver broke, and the tip of the screwdriver remained in the screw head.The surgeon cut the screw head with a carbide drill and used the hollow reamers to remove the shaft of the screw.The tip of both hollow reamers chipped off when the surgeon was reaming the bone.After excavating the bone with the chipped hollow reamer, the screw was removed by grasping with pliers, and a total hip arthroplasty was performed.The surgery was completed successfully with a 45 minute delay.The adverse health effects caused by this event were as follows: increase in the amount of bleeding associated with prolonged operation time, prolongation of anesthesia time, excessive bone excavation associated with screw removal, and additional use of physiological saline for removal of iron powder associated with excavation.Concomitant device: unknown screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) hollow reamer complete for 6.5mm & 7.0mm screws.This is report 2 of 4 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: a product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that hollow-reamer-compl anticlockwise cuttin the reamer was broken at the tip, and broken piece was not returned no other issues were identified.The dimensional inspection was not performed sue to post manufacturing damage.The observed condition hollow-reamer-compl anticlockwise cuttin in 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 broken condition of the hollow-reamer-compl anticlockwise cuttin.While no definitive root cause could be determined, it is probable that the hollow-reamer-compl anticlockwise cuttin was broken due to the unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.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.H3, h4, h6: a device history record (dhr) review was conducted: part # 309.450, lot # 26p3155, manufacturing site: bettlach, release to warehouse date: 11 march 2020.A manufacturing record evaluation was performed for the finished article lot 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.
 
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: 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.
 
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Brand Name
HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0MM SCREWS
Type of Device
REAMER
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key12175056
MDR Text Key261810097
Report Number8030965-2021-05782
Device Sequence Number1
Product Code HTO
UDI-Device Identifier07611819018396
UDI-Public07611819018396
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 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number309.45
Device Lot Number26P3155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
HOLLOW-REAMER-COMPL ANTICLOCKWISE CUTTIN; PL 2HO F/FEM NECK SYST TAN; UNK - SCREWS: FNS LOCKING; HOLLOW-REAMER-COMPL ANTICLOCKWISE CUTTIN; PL 2HO F/FEM NECK SYST TAN; UNK - SCREWS: FNS LOCKING
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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