MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH GUIDEWIRE ¿3.2 F/PFNA BLADE

Catalog Number	356.830
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient age was listed between ages 40-50, patient identifier, date of birth, age and weight not available for reporting.Device was re-assessed based on initial investigation requirements and was deemed reportable on january 19, 2018.Lot was identified as either lot# l572079 or l572078.It was undetermined which lot was impacted.Device is an instrument and is not implanted/explanted.Without a definitive lot number the device history records review could not be completed.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 during a proximal femur nailing on (b)(6) 2017, a k wire sheared off intraoperatively.During insertion of the drill over the k-wire, the k-wire was cut through by the drill.Back up instrumentation was used to complete the surgery successfully.A fifteen (15) minute surgical delay was reported.Concomitant devices: drill bit (part# 03.037.022, lot# f-16763, qty 1).Insertion handle (part# 03.037.011, lot# 8921813, qty 1).Connecting screw (part# 03.037.010, lot# 9219128 qty 1).Aiming arm (part# 03.037.114, lot# l178546 qty 1).Trocar (part# 03.037.019, lot# 9079765, qty 1).Aiming arm locking device (part# 03.037.015, lot# l122025, qty 1).Compression nut (part# 03.037.016, lot# 8947771, qty 1).Guide wire sleeve (part# 03.037.018, lot# 8901948, qty 1).Screw guide sleeve (part# 03.037.017, lot# 9066435, qty 1).Guide wire (part# 356.830, lot# l572079 or l572078, qty 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Therapy date: (b)(6) 2017.A device history record (dhr) review was performed for part number: 356.830, synthes lot number: l572079, release to warehouse date: 16 oct 2017, manufacturing site: (b)(4), no non-conformance reports (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.A device history record (dhr) review was performed for part number: 356.830, synthes lot number: l572078, release to warehouse date: 13 oct 2017, manufacturing site: (b)(4), no non-conformance reports (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.A product investigation was performed.Two of the three returned guide wires present damages as follows: guide wire 356.830, lot: unknown (possible lot numbers identified as l572079 or l572078): threaded tip is cut off and missing.Guide wire part # unknown: two centimeter behind the tip a deep cut is visible.Both guide wires show fretting marks over the whole length, which makes it impossible to identify the exact part and lot numbers.The review of the device history records (for lot # l572079 and l572078) revealed that both lot numbers were manufactured in october 2017 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.Diameter of the guide wires, measured at an undamaged area, measures 3.19mm, which comply with the specifications.Further dimensional inspection could not be performed due to the damage incurred.The guide wires are made from stainless steel (1.4441).A function check with the returned instruments was performed and didn't show any abnormalities.The assembly of the instruments did work as intended.The guide wire is guided through drill sleeve (03.037.018); this ensures the correct alignment of the guide wire.The trocar has no influence onto the alignment.Neither a product nor a function fault could be detected.Although the exact cause cannot be determined, this complaint condition is likely a result of method of use.Lateral strain during use might have caused a slight bending of the guide wire and foster the reamer to cut into the wire.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Corrected data: physical manufacturer: 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
Further it was reported that the tip of the guide wire was not left behind in the patient, the tip was removed from the patient and was discarded.

• Brand Name: GUIDEWIRE ¿3.2 F/PFNA BLADE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7209061
• Report Number: 8030965-2018-50522
• Device Sequence Number: 19129162
• Product Code: FZX
• UDI-Device Identifier: 07611819291355
• UDI-Public: (01)07611819291355(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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: 356.830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1