MAUDE Adverse Event Report: SYNTHES SELZACH MINIMALLY INVASIVE SYSTEM (MIS) FRACTURE CLAMP ¿ STERILE; MISC ORTHO SURGICAL INSTR

Catalog Number 04.628.101S

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information not available for reporting.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 (b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review - manufacturing location: (b)(4).Manufacturing date: 30 november 2015.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.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 (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2016 surgeon experienced difficulties during a universal spine septum (uss) fracture mis case.Specifically, the rod holder would not grip the rod sufficiently to keep the rod rigid and the sleeve on the rod holder would not remain in place and instead kept slipping back up the shaft, making it extremely difficult to place the rod.The surgeon reportedly had trouble with one of the sterile clamps popping off the end of the clamp holder; when a new clamp was used the problem was resolved.There was a reported one (1) hour surgical delay and no patient harm.The surgery was successfully completed.This is report 3 of 3 for (b)(4).

Manufacturer 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.

Manufacturer Narrative

Manufacturing investigation evaluation: the part was received in a minigrip assembly with all components present.However, one (1) component was wrongly assembled.The received components were: part 60071400 (clamp body), part 60071402 (collet), part 60071403 (washer), and part 60071401 (nut with 3 lobe drive).Based upon the visual inspection, the nut with its three (3) lobe drive is reverse screwed into the collet.This finding is not related to the complaint description since the issue was with the coupling between the clamp body and the clamp holder.However, the assembling step was checked in order to verify if the wrong assembly could have occurred in (b)(6).According to the assembling procedure, the nut is tightened with a torque wrench.The torque to be used needs to be coupled with the 3 lobes of the nut.In order to complete this step, the nut must be assembled correctly.A wrongly assembled nut is not compatible with the steps to be followed during assembling process.The component involved in the complaint issue is the clamp body (part 60071400) as this component is coupled with the clamp holder.To fully inspect the clamp, it was necessary to disassemble the other components.The characteristics pertinent with the complaint description were all measured with 3d machine.All of the characteristics were conforming to specifications.Product investigation summary: the received clamp has some wear marks at the place where the clamp holder is attached.The anodized layer is worn out at all marks, which indicates that they were caused post-manufacturing.Also, it was discovered that the nut with 3 lobe drive was reversely screwed into the collet, preventing a tightening of the nut.It is assumed that this incorrect assembling was caused post-manufacturing as the nut is tightened with a torque wrench during manufacturing and this tightening is only possible when the nut is placed the right way.In this relation, it is important to point out that the surgical technique mentions that, in case of mis fracture clamp disassembling, ensure the correct reassembling of the implant with the orientation of the washer and of the nut according to the picture.The manufacturing documents of the clamp were reviewed and no complaint related issues were detected.This lot of (b)(4) was manufactured in july, 2015.The fracture clamp was forwarded to the manufacturing site where a complete re-inspection of the complaint relevant dimensions was conducted.The inspection has shown that the clamp is according to the specifications and no manufacturing related issues were detected.Based on the provided information, and without the involved rod, the exact root cause of this occurrence could not be determined.Device history record review: manufacturing location: (b)(4) - manufacturing date: december 10, 2015 - expiry date: december 1, 2025.The review of the sterile manufacturing documents is not needed as the reported complaint condition is related to the non-sterile part.(b)(4).Device 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: MINIMALLY INVASIVE SYSTEM (MIS) FRACTURE CLAMP ¿ STERILE
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5471751
• MDR Text Key: 39767668
• Report Number: 1000562954-2016-10043
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.628.101S
• Device Lot Number: 9760027
• Other Device ID Number: (01)07611819476202(10)9752193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• 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