MAUDE Adverse Event Report: SYNTHES ELMIRA TI SNAP-ON TRANSCONNECTOR 62MM-90MM FOR 5.5MM/6.0MM RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.633.364S

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: the transverse connector was too stiff to adjust the length, once loosened, the set screws remained stuck.In addition, the metal strip came out from the set screws tip and another implant was used to complete the operation.No harm to the patient.This is 1 of 1 for report (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional device codes: mnh, mni, kwq, kwp.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the raw material device history record revealed this lot met all specifications at time of acceptance.No nonconforming reports were noted.The raw material met all dimensional and visual criteria at the time of release with no issues documented.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.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: a manufacturing evaluation was completed: assembly was in good condition, no apparent damage to machined components.Translation screw damaged.Translation screw was removed and first thread is peeled back about 1 revolution.This screw is staked at the bottom so it cannot be removed without damaging the screw.T-rod sticks in the closed position and may have been damaged on end by translation screw removal.The snap-on transverse connector is preassembled and requires only finial positioning and tightening, so based on the investigation results from the manufacturing site it would appear that user error was the root cause for this complaint.In addition based on how the part was returned, it was not possible to define what caused the initial stiffness of this device.The technique guide was referenced.A review of all manufacturing records was conducted and there were no factors that would have contributed to this complaint condition.The article was manufactured in the us meeting all specifications.A review of our complaint history for this part was conducted.No product fault could be detected.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: TI SNAP-ON TRANSCONNECTOR 62MM-90MM FOR 5.5MM/6.0MM RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3800744
• MDR Text Key: 4526171
• Report Number: 3003506883-2014-10049
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.633.364S
• Device Lot Number: 7606265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1