MAUDE Adverse Event Report: SYNTHES HAGENDORF 12.0MM/8.0MM PROTECTION SLEEVE188MM; TRAY,SURGICAL INSTRUMENT

Catalog Number 03.010.063

Device Problem Difficult to Advance (2920)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 during a retrograde femoral nailing procedure on (b)(6) 2016, the protection sleeve would not advance in the aiming arm therefore; the surgeon had to mallet the device down and it would not slide back out.There were no other devices available for the procedure therefore the surgery was completed with these devices.There was a 5-7 minute surgical delay due to the malleting of the device.There was no harm to the patient and the status of the patient after surgery was reported as good.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (12.0mm/8.0mm protection sleeve188mm, part number 03.010.063, lot number 1367311).The subject device was returned with the complaint that the protection sleeve would not advance in the aiming arm.The aiming arm for retrograde standard locking (03.010.050) is utilized in the titanium cannulated retrograde/antegrade femoral nail system when a retrograde approach and standard locking is desired.The aiming arm is connected to the insertion handle after which the triple trocar (03.010.063, 03.010.062/03.010.066 and 03.010.070/03.010.071) can be inserted through one of the two lm holes and the screw insertion process can take place: stab incision, drill, measure, locking screw insertion; the process is repeated for insertion of the second distal locking screw per the system technique guide.Relevant drawings for the protection sleeve were reviewed.Revisions were implemented after the manufacture of the returned protection sleeve to ease the outer diameter transition in order to improve product performance and preserve product life of mating instruments.The outer diameter dimension of the returned device was compared to the drawing specification and was found to be within the tolerance (measured 11.96mm, specification 11.96-11.98mm).Additionally relevant drawings for the aiming arm were also reviewed.Lm hole sizes of the returned device were measured using pin gauges and were found to be within specification in each instance (measured 12.01, specification 12.0-12.03mm).The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instrument¿s lot numbers and in each instance no mrrs, ncrs or complaint-related issues were identified with the lots numbers which may have contributed to the complaint condition.The returned instruments were examined and the complaint condition was unable to be replicated as the protection sleeve is able to pass through both lm holes in the aiming arm.Further examination found severe scoring on the shaft of the protection sleeve.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12.0MM/8.0MM PROTECTION SLEEVE188MM
• Type of Device: TRAY,SURGICAL INSTRUMENT
• 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: 5396212
• MDR Text Key: 37009477
• Report Number: 3003875359-2016-10051
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.063
• Device Lot Number: 1367311
• Other Device ID Number: (01)10886982067371(10)1367311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2005
• 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: 79 YR
• Patient Weight: 65