MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDE WIRE AIMING DEVICE F/TFN FOR ANT POSTERIOR ORIENTATION

Catalog Number	03.010.412
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) reports an event as follows: it was reported that during an unknown procedure on an unknown date, a silver pin from a connecting screw for proximal femoral nail antirotation (pfna) was missing.The instrument was not needed during the procedure, so there were no adverse outcomes.It was noted that the pin has been missing for a while.Procedure outcome is unknown.This report is for a guide wire aiming device.This is report 1 of 1 for (b)(4).
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: 03.010.412; lot: 13f6523; manufacturing site: selzach; supplier: createc gmbh & co.Kg; release to warehouse date: june 19, 2013 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 criteria at the time of release with no issues documented during the manufacturing process.Certificate was reviewed and has revealed that the item identified along with the required documentation, was according to specification.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.Investigation selection: investigation site: cq zuchwil, selected flow(s): 4.Visual | examples: missing feature or component/peeling coating/corrosion/temperature sensitive indicator and 5.Broken.Visual inspection: upon visual inspection of the complaint device, it can be seen that the part is not broken, but it is clearly visible that one of those two pins is missing, this thus confirming the complaint description.Furthermore, by the thread there chipped off a bit from the part, as well the part has some signs (scratches on the surface) from us.Otherwise, the article in a good condition.Document/specification review: drawings and revisions are in accordance to device history record (dhr) of production lot.All relevant features are defined on the used drawing revisions of dhr of production lot.A dhr review was performed for the affected lot; 50 parts were delivered to the warehouse, no abnormalities or deviations were detected which could lead to the complaint failure.The article was manufactured in june 2013.No nonconformance reports (ncrs) were marked in the dhr during production.Furthermore, the dhr review has shown that the pins were secured and sealed according to specification.Dimensional inspection: during investigation, the following measurements were measured.Caliper 03-01-20766, measure 30.00 +/-0.20mm, the measure result is within accuracy (29.86mm), and measure 4.60 +/-0.10mm, the measure result is within accuracy (4.62mm).Micrometer 3-03-17585, measure 15.00 +/-0.06mm, the measure result is within accuracy (14.98mm/2.40mm).Material or hardness review: certificate was reviewed and has revealed that the item identified along with the required documentation, was according to specification.Summary: unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that wear and tear from often use over the years (as the instrument is over 5 years old) led to this damage or/and that during the operation an application error may have taken place.To prevent such problems, it is necessary for worn or damaged instruments to be replaced and/or to be operated according to the technique guide.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.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.

• Brand Name: GUIDE WIRE AIMING DEVICE F/TFN FOR ANT POSTERIOR ORIENTATION
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8046665
• Report Number: 8030965-2018-57996
• Device Sequence Number: 11183440
• Product Code: FZX
• UDI-Device Identifier: 07611819349490
• UDI-Public: (01)07611819349490
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 10/23/2018

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: 03.010.412
• Device Lot Number: 13F6523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 11/23/2018; 12/11/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/10/2018; 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1