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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 20MM SCREW, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM SCREW, FIXATION, BONE Back to Search Results
Catalog Number 04.210.120
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

No patient involvement was reported. Additional product code: hrs. Device was received damaged and was not implanted / explanted. (b)(6). Dhr review was completed. Item: 04. 210. 120 , lot: h339968 , mfg qty: (b)(4), mfg date: 28 apr 2017 , mfg location: (b)(4). Inspections were performed and passed. Product was packaged as required. Dhr shows there were (b)(4) labels printed; (b)(4) pieces at the packaging operation; (b)(4) labels used on product and 1 label on the packaging label log. There were no ncs or reworks generated during the manufacture of this lot. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Customer quality conducted an investigation of the returned device. Investigation as received: package was returned for evaluation and examined. There is no screw inside package. Package was sealed and no holes were visible in package. Package has correct lot and part number. Received empty bag was measured against the drawing in which it meets specification for bag (50. 8mm x 170mm). Investigation summary : the product review supports the complainant¿s description of the complaint condition therefore this is a confirmed compliant. A review of the manufacturing history for this part does not show any indication that an empty package existed in the lot, however the cause of the complaint condition would be determined as operator error in which the operator did not place a product in the package during the processing of this lot. Process risk. Production risk management document addresses complaint condition (empty package); worst case severity of harm is 1. (b)(4). The estimated yearly probability of occurrence and harm are in alignment with product risk acceptance matrix. Conclusion. The complaint condition is confirmed, as an empty, sealed, intact package was delivered to a customer. No product design issues were identified during the investigation, however, a manufacturing issue was identified. Appropriate steps have been taken to address the non-conformance. The need for further corrective/preventative action as well as any additional risk assessment will be addressed within the nonconformance record. 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 europe reports an event in (b)(6) as follows: it was reported the package for the 2. 4mm variable angle (va) locking screw was received sealed but empty. No patient or surgery was involved. This report is for one (1) 2. 4mm va locking screw (b)(4).

 
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Brand Name2.4MM TI VA LOCKING SCREW STARDRIVE 20MM
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7805084
MDR Text Key117868113
Report Number8030965-2018-55878
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK103243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number04.210.120
Device LOT NumberH339968
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/28/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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