MAUDE Adverse Event Report: SYNTHES BRANDYWINE BUTTRESS/COMPRESSION NUT FOR 357.369; TRACTION,APPARATUS,NON-POWERED

Catalog Number 357.371

Device Problems Disassembly (1168); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

It was reported during a hip fracture procedure that the buttress/compression nut and 130 deg aiming arm f/trochanteric fixation nails kept detaching intraoperative.Delay in surgery 5-10 minutes.The same parts were used to complete the surgery.The procedure was completed successfully with no patient harm.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history review was conducted.The report indicates that the review of the dhr for work order# (b)(4), lot# 4820576 showed material review record (mrr) # (b)(4) written on operation# 14 for (v) uneven ep finish on 23 out of 80 parts.Nonconforming parts were reworked as documented in section 4 of mrr.The rework operations documented were reviewed w/bb operator, re ¿bb, ep per op 14, and inspected for even finish.The final accepted quantity was 80 parts as 23 parts passed inspection for even finish.The nonconformities documented on this mrr# (b)(4) are unrelated to the complaint condition as the nonconforming parts were identified, reworked and accepted.A review of the dhr indicates there were no other relevant issues during manufacturing which could have caused or contributed to this complaint.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

Device was used for treatment, not diagnosis.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.Since the lot number has been corrected, a new request has been made for review of the device history records.Device manufacture date: unknown, pending updated device history record review.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

After receiving an updated lot number, a new device history records (dhr) review as completed: the review of the dhr showed material review record (mrr) written for (t1) m18x1.5-6h go does not go (very tight) on 5 out of (b)(4) parts.There was 100% re-inspection performed using thread gage at nominal.As result of this re-inspection, (b)(4) parts passed and (b)(4) failed as documented.The final accepted quantity was (b)(4) parts as a total of (b)(4) parts were scrapped.The nonconformities documented on this mrr are unrelated to the complaint condition as the nonconforming parts were identified and scrapped.A review of the dhr indicates there were no other relevant issues during manufacturing which could have caused or contributed to this complaint.All other records indicate the part was manufactured to specifications.A product development evaluation was completed: the buttress/compression nut has visible signs of wear about the area which mates with the aiming arm.Per the technique guide, the 130° aiming arm and buttress/compression nut are components of the titanium trochanteric fixation nail (tfn) system intended for the intramedullary fixation of proximal femur fractures.A complaint was reported against two parts, one 130° aiming arm (part 357.366, lot 4781337, manufactured may 2003), and one buttress/compression nut (part 357.371, lot 4537310, manufactured september 2004).Upon receipt of these devices it was seen that both devices have visible signs of wear, which has resulted in a minor loss of material at the nut/aiming arm interface on both parts.When the two devices were mated together, they easily detached without utilizing the release mechanism on the aiming arm.This complaint is confirmed.The drawing for the buttress/compression nut was reviewed and the design, material and finishing processes are appropriate for the intended use of this device.This complaint is confirmed given that the returned devices do not connect securely.Given the age of these devices and the wear marks they contain, this complaint is likely a result of regular use over time.The designs of these devices were found to be adequate for their intended uses and did not contribute to this 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.

• Brand Name: BUTTRESS/COMPRESSION NUT FOR 357.369
• Type of Device: TRACTION,APPARATUS,NON-POWERED
• 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: 4387432
• MDR Text Key: 5309701
• Report Number: 2530088-2015-10006
• Device Sequence Number: 1
• Product Code: HST
• 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: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.371
• Device Lot Number: 4537310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2003
• 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 Age: 76 YR