MAUDE Adverse Event Report: SYNTHES HAGENDORF THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES

Catalog Number	323.029
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: patient date of birth was not provided for reporting.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Device history records review was completed for part# 323.029, lot# 3245569.Manufacturing location: (b)(4), manufacturing date: sep 15, 2009.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that the threads on a threaded locking compression plate (lcp) drill guide would not engage with the hole of the variable angle distal radius plate during an open reduction internal fixation (orif) of the distal radius procedure on (b)(6) 2017.A second drill guide from the same set was used to proceed with surgery.The plate was not damaged and was implanted in the patient.No medical intervention required.Surgery was successfully completed with a thirty seconds surgical delay.The delay was due to getting the second drill guide.Patient status/outcome was reported as stable.Concomitant device reported: variable angle distal radius plate (part# unknown, lot# unknown, quantity 1).This report is for one (1) threaded lcp(tm) drill guide f/lcp(tm) distal radius plates.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental 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.
Additional Manufacturer Narrative
A product investigation was completed: this complaint is confirmed.Visual inspection under 5x magnification revealed damage to the distal most two (2) thread-forms.The distal most two (2) thread-forms are no longer smooth/symmetrical.The post-manufacturing damage on this 7+year old reusable instrument is most likely a result of force/leverage applied to this device while not fully threaded into a plate.No new malfunctions were identified.A visual inspection under 5x magnification, device history record (dhr) review, technique guide review and drawing review were performed as part of this investigation.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The returned 1.8mm threaded lcp drill guide is a reusable instrument available for use in several systems/technique guides and can be used to aid in fracture reduction with kirschner wires, or to aid in co-axial drilling, as well as screw length determination.The relevant drawing was reviewed during this investigation.No product design issues or discrepancies were observed.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6395189
• Report Number: 3003875359-2017-10104
• Device Sequence Number: 18841594
• Product Code: FZX
• UDI-Device Identifier: 10886982190598
• UDI-Public: (01)10886982190598(10)3245569
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2017

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: 323.029
• Device Lot Number: 3245569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/03/2017; 04/11/2017
• 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: ONE (1) UNKNOWN VA DISTAL RADIUS PLATE
• Patient Weight: 101