MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight are unknown.The patient¿s exact age is unknown; however, age was reported as being in the (b)(6).(b)(4).Device is an instrument and is not implanted or explanted.It is unknown at this time if the complainant part will be returned for evaluation.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

Event Description

Device report from synthes (b)(4) reports an event in the (b)(6) as follows: it was reported that a patient underwent a tibial and femoral nailing procedure on (b)(6) 2016 in order to address a diagnosis of floating knee.During the procedure, the surgeon noted that the patient had a very narrow intramedullary canal in both the femur and the tibia.Upon first reaming of the tibia, the head of an 8.5mm reamer head sheared into two (2) pieces.As the reamer head broke, it took some of the engagement splines off of the end of the reamer shaft as well.The reamer shaft was withdrawn.An intra-operative x-ray confirmed the presence of retained fragments; pieces of the head and the tip of the shaft remained in the patient.Reaming was completed with a second set that was on-hand.The implantable nail was then inserted past the debris, thus completing the surgery with a five (5) minute prolongation.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be 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 Description

It was confirmed that the procedure was successfully completed.

Manufacturer Narrative

Product investigation summary: all (b)(4) prongs at the forefront of the received flexible shaft are sheared off.(b)(4) of the prongs were sent back for evaluation.All of them were badly twisted before breaking off.The device is in a very used overall condition with the laser etching faded.Also, there are strong tool marks at the top hexagon, strong stress marks all over the shaft, and the hexagon at the forefront is totally worn.Due to the damage at the forefront of the device, the relevant dimensions could not be verified.The review of the manufacturing documents has shown that the device was manufactured according to the specifications with a lot size of (b)(4) pieces.The documents show that, with stainless steel (b)(4), the correct material was used for the coupling.The hardness of this lot was between (b)(4) hv 0.5, which is within the specifications of (b)(4) +/-20 hv 0.5 according to the drawing.These findings, along with the very used condition of the device, indicate that the device was often used without any prior issues.Afterwards, it cannot be defined if the hexagon of the reamer coupling was already worn before the procedure or if this occurred during the procedure.There sheared off appearance of the fracture face and the strongly twisted prongs are an indication for a mechanical overload during reaming.Device history record review: manufacturing site: (b)(6) - manufacturing date: march 23, 2011.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5705359
• MDR Text Key: 46769693
• Report Number: 2520274-2016-13054
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Device Lot Number: 2707520
• Other Device ID Number: (01)07611819243668(10)2707520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention