MAUDE Adverse Event Report: SYNTHES BRANDYWINE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS; GAUGE, DEPTH

Catalog Number 357.402

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Manufacture dates: april 14, 2010.The review of the (b)(4) device history record showed that there were no issues or non-conformances during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: the complaint condition of loose is confirmed on both devices as upon visual inspection; it can be seen that the ball bearing on the internal slider on the complaint device is missing.The distal hooked tip of the devices is undamaged.It is unknown what caused the complaint condition, but it is most likely due to wear over the life of the device.Per the technique guide, the 357.402 locking bolt measuring device is an instrument routinely used in the titanium trochanteric fixation nail system to measure locking bolt/screw length.The relevant drawings were reviewed.The design history was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.It is most likely this failure mode was due to the method of use or damage during sterile processing while in a disassembled state 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 reported while re-assembling two locking bolt measuring devices f/trochanteric fixation nails during sterile processing, they fell apart.The little ball inside to mark the compression was missing that makes the sleeve to slide gradually.There was no patient involvement and no procedure.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

(b)(4).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: LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS
• Type of Device: GAUGE, DEPTH
• 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: 5274220
• MDR Text Key: 32925334
• Report Number: 2530088-2015-10718
• Device Sequence Number: 1
• Product Code: HTJ
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.402
• Device Lot Number: 6365027
• Other Device ID Number: (01)10886982196255(10)6365027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2010
• 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