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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPARE REAMER TUBE FOR HOLLOW REAMER (309.065) Back to Search Results
Lot Number 2394788
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/11/2018
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Patient code (b)(4) used for: the reamer broke intraoperatively, and fragment remains in the patient.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.(b)(4).
 
Event Description
It was reported that on an unknown date, a patient underwent a hardware removal of an unknown broken device.As per surgeon, it was more of a risk to take the broken device out so it was left in the patient.The unknown screw they were in the process of removing was removed successfully.The reamer that broke is a one time use item placed in the broken screw removal set and processed in sterile processing department.The shukla medical screw removal set was the one they originally wanted but had a hole in the blue wrap.Patient and procedure outcome is unknown.This complaint one (1) device.This report is 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.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 further reported that the reason for the removal procedure is unknown.The removal was conducted on (b)(6) 2018.The reamer tube broke during an attempt to remove the broken unknown screw.The broken portion of the trephine (reamer tube) was reportedly left inside the patient.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) spare reamer tube for hollow reamer.
 
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.A device history record (dhr) review was conducted: lot number 2394788 indicates component 36598 which is part of the complete part as described in the complaint.Part: 309.068.Lot: 2394788.Manufacturing site: bettlach.Release to warehouse date: 27.Oct.2008.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The material was reviewed and was confirmed to meet the specification with no (relevant) non-conformance noted.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Visual inspection: the spare reamer tube for hollow reamer (part # 309.068, lot # 2394788, mfg # 27-oct-2008) was received at us cq broken unevenly.Very jagged edges were created when the device broke.This is consistent with the reported complaint condition, thus confirming the complaint.There are also signs of discoloration/rusting/corrosion at the cutting edge of the reamer tube.Medical images were not provided therefore the embedded condition cannot be confirmed by cq.Also, no fragments were returned to cq.Dimensional inspection: dimensional analysis was completed, the outer diameter of the shaft measured and is within specification based on relevant drawing.The inner diameter measured and is within specification based on relevant drawing.Document/specification review: the relevant drawing(s) was reviewed; the material was reviewed and was confirmed to meet the specification with no (relevant) non-conformance noted.Conclusion: the complaint condition is confirmed as the device (part # 309.068, lot # 2394788) was received with the reamer tube broken.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)
Type of Device
REAMER
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
PA 19380
MDR Report Key7967463
MDR Text Key123795429
Report Number2939274-2018-54390
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10886982185587
UDI-Public(01)10886982185587
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number2394788
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2018
Date Manufacturer Received11/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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