MAUDE Adverse Event Report: SYNTHES BRANDYWINE 4.2MM TROCAR 210MM; TRAY, SURGICAL INSTRUMENT

Catalog Number 03.010.070

Device Problem Fitting Problem (2183)

Patient Problem Sedation (2368)

Event Date 05/04/2015

Event Type  Injury  

Event Description

It was reported that an aiming arm would not line up with a femoral nail and this prevented proximal locking.There was a delay between 20-30 minutes, while the surgeon was trying both the static and dynamic holes.There was no reported harm to the patient.The procedure was successfully completed.The fracture appeared stable, so patient outcome looks to be positive.This report is 2 of 7 for (b)(4).

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history review: manufacture date: october 18, 2007.The device history records were reviewed and no issues were found during manufacture that would contribute to the 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

Device was used for treatment, not diagnosis.The subject device has been received and is currently in the evaluation process.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: product investigation summary: the complaint condition for the recon locking aiming arm (part 03.010.048 / lot 4963190), percutaneous insertion handle (part 03.010.046 / lot 1448915), 12.0mm/8.0mm protection sleeve (part 03.010.063 / lot 1802328), 8.0mm/4.2mm drill sleeve (part 03.010.065 / lot 1753339), and the 4.2mm trocar (part 03.010.070 / lot 5611943) was likely caused by a soft tissue obstruction or insufficient tightening of the aiming devices; however, this complaint is not likely a result of any design related deficiency.No non-conformance reports were generated during production.A review of the device history record(s) showed that there were no issues during the manufacture of the products that would contribute to the complaint condition.The recon locking aiming arm, percutaneous insertion handle, 12.0mm/8.0mm protection sleeve, 8.0mm/4.2mm drill sleeve, and the 4.2mm trocar are instruments routinely used in the titanium cannulated lateral entry femoral recon nail system.The devices were returned and reported to have contributed to the aiming arm not lining up for proximal locking with the nail.This condition is unconfirmed; when tested with a titanium cannulated lateral entry femoral recon nail (part 04.003.245 / lot 7533617) and a cannulated connecting screw (part 03.010.146 / lot u197773), the devices align properly with the nail¿s proximal locking holes.It is likely that soft tissue obstructed the path of the locking screws or that the aiming devices were not fastened together entirely leading to this complaint condition.The trocar is in good condition with surprisingly few signs of wear given its age.The associated drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does not agree with the complaint description.The complaint condition for this device cannot be replicated.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: 4.2MM TROCAR 210MM
• Type of Device: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4792210
• MDR Text Key: 5805450
• Report Number: 2530088-2015-10444
• Device Sequence Number: 1
• Product Code: FSM
• 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

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.070
• Device Lot Number: 5611943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2007
• 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
• Patient Age: 20 YR
• Patient Weight: 98