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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM; SCREW, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 04.210.110
Device Problem Incomplete or Missing Packaging (2312)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.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.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 there is no product present inside a new unopened package.This complaint involves 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 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.
 
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: manufacturing location: monument manufacturing date: 10-jan-2019, part number: 04.210.110, 2.4mm ti va locking screw stardrive 10mm, lot number: h810269 (non-sterile), lot quantity: 240.Work order traveler met all inspection acceptance criteria.Inspection sheet, mill shaft threads / head thread / flute met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.A total of 241 labels were printed; 240 labels were placed on product and 1 label was used on the pll.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿no product present inside unopened package¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the package for part number 04.210.110, lot h810269 was returned for evaluation and examined by the quality engineer.The package does not contain screw contents; therefore, the review supports the complainant¿s description of the complaint condition.Therefore, this complaint is confirmed from a manufacturing standpoint.Document/specification review: manufacturing review: part number 04.210.110, lot number h810269 was manufactured in january 2019.There were no issues with the pll reconciliation for this lot.There is no evidence to suggest the operator did not follow their process.The assignable cause is material: handling as the packaging operation is 100% manual.Nc review: a 1-year review was completed for related nonconformities for part family (02.210.106 ¿ 02.210.160 & 04.210.106 ¿ 04.210.160).No related issues were found for a 1-year period from 20-dec-2019 to 20-dec-2019.Product complaint review: the complaint data was reviewed for a 3-year period from 18-dec-2016 to 18-dec-2019 for valid complaints for empty packages for all 2.4mm ss/ti variable angle screws (02.210.106 ¿ 02.210.160 & 04.210.106 ¿ 04.210.160).The review found 2 complaints: (b)(4) (this complaint) for part number 04.210.110 and (b)(4) for part number 02.210.114.Conclusion: the monument packaging process is specific to each production order.Therefore, packaging defects are specific to the packaging event in which they occurred.In conclusion, there is no indication of a systemic issue and the probability of occurrence is improbable for empty package nonconformities.Relevant actions have been taken to address the issue.A sealed, intact empty package was delivered to a customer.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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
2.4MM TI VA LOCKING SCREW STARDRIVE 10MM
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9438478
MDR Text Key195404961
Report Number8030965-2019-70927
Device Sequence Number1
Product Code HWC
UDI-Device Identifier07611819980204
UDI-Public(01)07611819980204
Combination Product (y/n)N
PMA/PMN Number
K103243
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 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.210.110
Device Lot NumberH810269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Date Manufacturer Received02/07/2020
Patient Sequence Number1
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