MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH POSITIONING SCREW FOR DISTAL RADIUS GUIDE BLOCK

Catalog Number	03.111.007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Lot number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that an on (b)(6) 2018, open reduction internal fixation (orif) with va-lcp (variable angle-locking compression plate) system was applied to distal radius fractures.When the surgeon tried to fix the guide block to a plate, the screw of the guide block broke off.This breakage occurred outside of patient¿s body, and fragment did not enter the patient.The fragment was removed from the plate, and the guide block was secured to the plate with a replacement screw.The surgery was completed within a 30-minute delay.There was no adverse consequence to the patient.Concomitant device: plate (part: unknown, lot: unknown, quantity: 1).This report is for a guide block for two-column plate/narrow 6h hd/rt.This is report 1 of 1 for (b)(4).
Event or Problem Description
This report is for a positioning screw for distal radius guide block.
Additional 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.Part: 03.111.007; lot: 3719195; manufacturing site: haegendorf; release to warehouse date: april 06, 2011.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.As this is an instrument, the used raw material is not lot tracked.Review of the device history record (dhr) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation site: cq zuchwil; selected flow: 5.Broken.Visual inspection shows that the shaft of the set screw is broken apart.The broken surface is homogeneous which indicates material conformity.In the area of the breakage, the shaft is plastically deformed which indicates mechanical overloading during use.The torx recess also shows several signs of high applied torsional force while locking.As this device is rather old and often used, we have to assume that mechanical overloading while locking the guiding block may have caused the breakage.The diameter of the shaft measured 1.45mm which is within the specification of (1.5mm 0/-0.1mm)) per drawing.Therefore, this complaint is classified as confirmed but no manufacturing related issue was found.As the root cause for the breakage could be identified, no further investigations are required.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.
Additional 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 evaluated by mfr: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Corrected data: concomitant medical products, device evaluated by mfr.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.

• Brand Name: POSITIONING SCREW FOR DISTAL RADIUS GUIDE BLOCK
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7703058
• Report Number: 8030965-2018-55163
• Device Sequence Number: 14146025
• Product Code: FZX
• UDI-Device Identifier: 07611819394407
• UDI-Public: (01)07611819394407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.111.007
• Device Lot Number: 3719195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/06/2018; 08/20/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/14/2018; 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .THERAPY DATE: JUNE 28, 2018