MAUDE Adverse Event Report: SYNTHES ELMIRA HELIX BLADE 90MM; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 282.237

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

Additional product code: ktt.Due to intra-operative issues, the device was not implanted/explanted.(b)(6).Part 282.237, lot 9882591: release to warehouse date: august 24, 2015.Manufacturing site: (b)(6).A review of the device history record (dhr) revealed no complaint related anomalies.The device history record shows this lot of helix blade 90mm product was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, an (b)(6)-year-old female patient, who had a hip fracture, was operated with dynamic hip screw system (dhss) equipment.As the doctor tried to insert the helix blade, it was identified that the device did not fit correctly to the plate.Due to this, the blade got stuck in the plate.The doctor proceeded with a clamp to remove the helix blade.The surgery was not prolonged and the patient status is good.Concomitant parts: plate (part/lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional information provided: as the doctor tried to insert the reported helix blade, it was identified that the device did not fit correctly to the plate.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.

Manufacturer Narrative

Additional narrative: following part was returned under (b)(4); lcp dhhs helixblade l90 sst (p/n 282.237, lot #s 9882591) - qty.1.Customer quality (cq) engineering investigation: the complaint condition could not be replicated at customer quality (cq) due to unavailability of lcp dhhs plate at the cq location.Visual inspection, device history record (dhr) review and drawing review were performed as part of this investigation.Visual inspection the balance of the returned helix blade is in good condition with minimal signs of superficial wear.The distal end of the device shows scratches which were probably made during efforts to separate the helix blade from the plate using clamp.No signs of deformities were observed on the blade that would affect it¿s functionality.Dhr review for part # 282.237 lot # 9882591.Release to warehouse date: 24 august 2015.Manufacturing site: (b)(4).Dhr record review: a review of the device history record revealed no complaint related anomalies.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Helix screw drawing was reviewed during this investigation.Following device features were measured which were found to be within specification.No design related issues were identified that would contribute to the complaint issue.Distal tip side-side width measured at 7.85mm (spec: 7.9mm +0/-0.05).Distal tip diameter measured at 7.10mm (spec: 7.15 mm +0/-0.05).Major flute axis diameter (proximal end) measured at 12.64mm (spec: 12.5mm +0.2/-0).Hence the complaint is unconfirmed as the concomitant dhhs plate was not returned and no issue with the returned helix screw was observed.Root cause: the returned part was determined to be suitable for the intended use when employed and maintained as recommended.Per the dhhs system technique guide, the helix blade is implanted in the bone first and then the plate is installed from the distal end of the helix blade.It may be possible that the surgical technique was not followed correctly based on the complaint description.On the other hand, the technique guide provides specific instruction to aid proper alignment of the plate and the helix blade.It recommends to use lcp dhhs key alignment shaft.Firstly the flats on the alignment shaft should be aligned with flats on the internal key on the sideplate.Later, the alignment of the hexagonal tip on the alignment shaft that meets with the end of the helix blade should be followed correctly.This ensures that the internal sideplate key and the helix blade shaft are properly aligned.Technique tip mentions that if the plate does not slide easily into the reamed cavity, gentle moving the alignment shaft up and down can assist the placement.Dhs/dcs impactor may also be used for further assistance.It is possible that one of the above steps critical for device alignment and assembly were not followed correctly which led to the devices being stuck together.The exact root cause could not be determined.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: HELIX BLADE 90MM
• Type of Device: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6710180
• MDR Text Key: 80145390
• Report Number: 3003506883-2017-10132
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 07611819736337
• UDI-Public: (01)07611819736337(10)9882591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 282.237
• Device Lot Number: 9882591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 08/04/2017; 08/08/2017
• Supplement Dates FDA Received: 08/04/2017; 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR