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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC POLY SCREW DRIVER RETEN SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
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DEPUY SPINE INC POLY SCREW DRIVER RETEN SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 2020-00-401
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Reporter is a synthes rep.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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.
 
Event Description
It was reported that on (b)(6) 2020, that the symphony screwdriver retainer sleeve is defective.The inner shaft will not slide down the retainer sleeve, therefore, it has been confirmed that the retainer sleeve as the inner shaft would slide down another retainer sleeve.Set has only been used 5 or 6 times.No apparent defect is visible, but something is damaged.This did not impact the case as another set was used.It was caught when scrub tech was setting up instruments before surgery.Two sets and one other bad retainer sleeve were checked.There is no patient involvement.This complaint involves two (2) devices.This report is 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.G4: the incorrect g4 date was inadvertently utilized in initial medwatch.The correct date is may 6, 2020.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the poly screw driver reten sleeve (p/n: 202000401, lot number: pc4976606) was received at us cq.Upon visual inspection, the most proximal thread on the device was broken.No other issues were identified with the returned device.Functional test: a functional assessment could not be performed on the complaint device since a mating device was not returned.Dimensional inspection: shaft inner diameter was measured and found to be conforming as per relevant drawing.Document/specification review: relevant drawings were reviewed and no design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as a functional test cannot be performed on the device to confirm the unable to assemble allegation.However, the most proximal external thread is broken.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: a review of the receiving inspection (ri) for poly screw driver reten sleeve was conducted identifying that lot number (b)(4) was released in a single batch.Batch1: lot qty of (b)(4) units were released on 30-jan-2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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
POLY SCREW DRIVER RETEN SLEEVE
Type of Device
CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key10070949
MDR Text Key191852092
Report Number1526439-2020-01038
Device Sequence Number1
Product Code GEA
UDI-Device Identifier10705034532776
UDI-Public(01)10705034532776
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
Type of Report Initial,Followup,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2020-00-401
Device Catalogue Number202000401
Device Lot NumberPC4976606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2020
Date Manufacturer Received06/22/2020
Patient Sequence Number1
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