MAUDE Adverse Event Report: SYNTHES HAGENDORF CANNULATED CONNECTING SCREW; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.037.010

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

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

Event Date 12/23/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient initials are (b)(6).Patient weight is 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.Device history record review: manufacturing location: (b)(4) - manufacturing date: july 30, 2015.No non-conformance reports were generated during production.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.

Event Description

It was reported that a surgeon experienced difficulty disengaging a cannulated connecting screw from a nail during a trochanteric fixation nail advanced (tfna) insertion procedure on (b)(6) 2015.The surgeon was eventually able to disengage the screw, but the issue resulted in a ten (10) minute surgical delay.The procedure was completed successfully with no reported patient harm.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product evaluation was performed.The investigation of the complaint articles indicates that: only the cannulated connecting screw was returned as part of this complaint.There are faint circular markings on the barrel of the screw, suggesting that the screw was temporarily trapped against the sides of the insertion handle.There is also metal debris in the threads of the connecting screw.There is wearing on the inner surface of the connecting screw consistent with normal use.This may have come from the nail as the surgeon was hammering during insertion, generating small amounts of debris that became stuck in the threads.If the residue was present when the connection was tightened, it could have jammed in the interface and increased the torque required to remove the screw.Another possible explanation is that blood or tissue entered the interface during the operation and increased the required removal torque.In the investigation, there was no difficulty in retaining the screw on an 8 mm ball-hex screwdriver, inserting the screw through an insertion handle, threading it into a tfna nail, and disassembling all components.Without the return of the nail, the precise cause of this complaint is unclear.Although the minor damage to the connecting screw supports the complaint description, the complaint event could not be replicated, and the exact cause is indeterminate.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: CANNULATED CONNECTING SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5363330
• MDR Text Key: 35796016
• Report Number: 3003875359-2016-10021
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131548
• 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: 12/23/2015

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: 03.037.010
• Device Lot Number: 9484329
• Other Device ID Number: (01)10886982070265(10)9484329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 01/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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: 64 YR