MAUDE Adverse Event Report: SYNTHES BETTLACH POSITIONING DEVICE FOR GUIDING BLOCK; GUIDE

Catalog Number	03.108.006
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Patient¿s weight is not available for reporting.Implant and explant dates: device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A device history record (dhr) review was performed for part # 03.108.006, lot # 2212902: manufacturing location: (b)(4), manufacturing date: 01.Dec.2006: 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.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 during a proximal femur osteotomy surgery performed on (b)(6) 2017, the positioning device for the guiding block would not lock into place.Every time the surgeon attempted to lock the block into place it would move, causing the guide wire not to be positioned properly.The device was able to be used, but because of it not locking in place properly, it complicated the procedure causing a one (1) hour delay in surgery.There were multiple x-rays taken to ensure that the guide wire was in the correct position.The x-rays are not available.The surgery was eventually completed successfully with no harm to the patient.Patient is reported as being in stable condition.Concomitant medical devices guide wire (part # unknown, lot #unknown, quantity 1).This report is for one (1) positioning device for guiding block.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
Product development investigation was completed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed at customer quality for the returned device as part of this investigation.This complaint is confirmed.The hex drive recess on the set screw that allows the user to secure the device to the mating instrument is rounded / stripped/worn and could cause or contribute to a condition of being unable to tighten the device as intended.The complaint condition was not able to be replicated at customer quality (cq) as the pediatric lcp hip plate guiding block (either part# 03.108.001 for 3.5mm screws or 03.108.002 for 5.0mm screws) was not returned for investigation and these are the devices that the returned part assembles to and the guidewire goes through.The returned device (positioning device for guiding block, part# 03.108.006) is a reusable instrument in the pediatric lcp plate system for use in osteotomies and fracture fixation of the proximal and distal femur.Instructions for use are provided in technique guide.Relevant drawings were reviewed during this investigation.Changes have been made to the device's design since the returned device was manufactured.However, it is determined that the design was adequate at the time of manufacture and the screw's rounded hex drive recess is due to cumulative wear for this 10+ year old reusable instrument.No product design issues or discrepancies were observed.No new, unique or different patient harms were identified as a result of this evaluation.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: POSITIONING DEVICE FOR GUIDING BLOCK
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6721442
• Report Number: 9612488-2017-10307
• Device Sequence Number: 1602028
• Product Code: FZX
• UDI-Device Identifier: 10886982071569
• UDI-Public: (01)10886982071569(10)2212902
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/27/2017

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: 03.108.006
• Device Lot Number: 2212902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 07/17/2017; 08/03/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 07/31/2017; 08/07/2017
• 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: GUIDE WIRE (PART # UNKNOWN, LOT #UNKNOWN, QTY UNK)
• Patient Age: 12 YR