MAUDE Adverse Event Report: SYNTHES (USA) 11.0MM TI HELICAL BLADE 120MM; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 456.309

Device Problem Mechanical Jam (2983)

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

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not available for reporting.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during a titanium trochanteric fixation nail system procedure to treat a hip fracture on (b)(6) 2016, the helical blade became stuck in the nail and would not advance.The nail and blade were removed and a different nail and blade were used to complete the procedure successfully without any further issues.The reported event caused a 10 minute surgical delay.A visual inspection by the reporter did not show any damage to the reported complained devices.The patient's post-operative condition was reportedly "fine".This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device became stuck intra-operatively and was not implanted/explanted.Corrected unknown nail to known nail 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

Concomitant devices reported: aiming arm (part and lot unknown, quantity 1) nail (part 456.317s, lot unknown, quantity 1) cannulated connecting screw (part and lot unknown, quantity 1) insertion handle (part and lot unknown, quantity 1).

• Brand Name: 11.0MM TI HELICAL BLADE 120MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5736824
• MDR Text Key: 47791915
• Report Number: 2520274-2016-13218
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011857
• 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: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 456.309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 82 YR