MAUDE Adverse Event Report: SYNTHES BETTLACH FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK; REAMER

Catalog Number 351.16J

Device Problems Component Falling (1105); Difficult to Insert (1316); Unintended Movement (3026)

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

Event Type  malfunction  

Event Description

It was reported that a jacobs chuck adapter came apart during a case.It was reported that the attachment for the reamers came apart after the little set screw that holds the quick coupling backed out, possibly from vibrations, and came apart.A back-up part was available.A surgical delay of five (5) minutes was noted and the procedure was completed without further issue.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: patient date of birth/age and weight are unknown.Event date: unknown.Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the service history records has been requested and is currently pending completion.Device history review: manufacturing location: (b)(4) - manufacturing date: april 4, 2014 a non-conformance report (ncr) was generated during production.Two (2) components had to be replaced as they were damaged.Afterwards, all parts were found to be ok.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.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.

Manufacturer Narrative

Additional narrative: a service and repair evaluation was completed: the customer reported the set screw backed out and the item fell apart.The repair technician reported the hole for the set screw was worn out.Worn out parts is the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit.The evaluation was confirmed.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: additional manufacturing date from service history april 09, 2014.Service history review: lot 8798091: no service history review can be performed as this is a lot controlled item.The service history evaluation is unconfirmed.A flexible shaft connector (351.16j lot 8798091) was reported to have come apart during a case as the setscrew backed out.The returned instrument was examined and the complaint was confirmed.The set screw seats within a groove cut into the instrument when the sleeve is aligned properly.In the case of the returned instrument, the sleeve was not properly aligned with the groove and as a result the set screw was not able to function to retain the internal mechanism which allowed the instrument to come apart.Per the technique guide, the 351.16j flexible shaft connector for jacobs chuck is an instrument routinely used in the flexible reamers for intramedullary nails.The set screw was not aligned with the groove it is intended to seat in, as a result the shaft connector was able to fall apart.The relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.A non-conformance report was generated during production.Two components had to be replaced as they were damaged.Afterwards, all parts were found to be ok.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.The root cause is consistent with incorrect assembly after sterilization.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: FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4791313
• MDR Text Key: 15903140
• Report Number: 9612488-2015-10284
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2015

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: 351.16J
• Device Lot Number: 8798091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/11/2015; 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2014
• 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