MAUDE Adverse Event Report: SYNTHES HAGENDORF APPLICATOR INNER SHAFT; INTERVERTEBAL FUSION DEVICE

Catalog Number 03.812.003

Device Problem Fitting Problem (2183)

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

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Implant and explant dates: device is an instrument and is not implanted/explanted.Initial reporter's phone number: (b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part: 03.812.003; lot: 8959887, manufacturing location: (b)(4), manufacturing date: 16.Jul.2014.No 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.Product development investigation was completed.Part #¿s evaluated: 2* 03.812.001; 2* 03.812.003; 2* 03.812.004.Investigation summary: customer returned six parts.The two inner shafts are broken on the proximal end.The two broken balls were found in the applicator knob.On the distal end are no signs of wear and tear or damage visible.On the outer shafts are close to the silicone handle strong stress and scratch marks visible.The distal end (thread) is in a good condition.It is likely that the breakage of the proximal balls was the result of excessive force during the implantation of the peek cage.The complaint description states that the surgeon hammered with the non-plastic side of the combined hammer, which probably lead to this damage.In the surgical technique guide, we recommend controlled and light hammering on the applicator to advance the implant into the intervertebral disc.Under normal circumstances and with light hammering the instruments should withstand the forces.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 on an event in (b)(6) as follows: the reported devices were used in surgery for the spinal canal stenosis related to the lumbar degenerative spondylolisthesis, stabilizing l4 and l5, on (b)(6) 2017.The surgeon applied t-pal (transforaminal posterior atraumatic lumbar cage system) and performed the following procedures.The surgeon filled the surgical area with transplant bone.He chose t-pal small cage h10 peek.By confirming the marking position, he hammered the knob with a combined hammer.In order to turn the cage, he also hammered the knob with the non-plastic hammering side.He turned the knob to the open direction and hammered the knob again.Then the knob became immobilized.So, he turned the knob to open direction and close direction several times.When he completely turned to the end of the close direction, the knob came off the handle.He changed to a replacing set of the reported handle, shaft and knob.With this replacing unit, he followed the same procedure as the prior trial.But the second trial resulted in the same failure, too.After the second failure, he re-inserted the cage with an unknown extracting instrument.Although he could not turn the cage completely, he thought that cage positioning seemed adequate.So, he finished the surgery with a 20-minute delay, no other medical intervention was required, procedure was successfully completed.There was no adverse consequence to the patient.This complaint involves 4 parts.Concomitant devices: a 1x 03.812.001 / 8446731 (applicat out shaft).1a x 03.812.001 / 8305057 (applicat out shaft).This report is 2 of 2 for (b)(4).

• Brand Name: APPLICATOR INNER SHAFT
• Type of Device: INTERVERTEBAL FUSION DEVICE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6662140
• MDR Text Key: 78360962
• Report Number: 3003875359-2017-10300
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819414600
• UDI-Public: (01)07611819414600(10)8959887
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151276
• 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
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.003
• Device Lot Number: 8959887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2014
• 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