MAUDE Adverse Event Report: SYNTHES USA; PIN, FIXATION, SMOOTH

Device Problems Sticking (1597); Appropriate Term/Code Not Available (3191)

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

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

The reported event occurred during a veterinary case.Therefore, no patient information will be reported.This report is for one (1) unknown jig pin.Device broke intra-operatively and was not implanted or explanted.(b)(4) the surgeon had to cut the pin in order to remove the sticking/jamming devices during the procedure.As specific part and lot numbers for the complainant pin were not provided.It is likely that the device is for vet use only.Product investigation summary: the following complaint device(s) were received for evaluation: one (1) standard tplo jig for use with 24mm/27mm/30mm saw guides, one unknown jig pin.The instrument is part of the standard tibial plateau leveling osteotomy system for stabilizing osteotomies of the canine proximal tibia.The jig attaches to bone with the use of a 3mm pin.The complaint condition was caused by not using the corresponding mating part for the instrument.Per the technique guide, the instrument is to be used with a 3.0mm kirschner, 150mm jig pin.Looking at the relevant drawing, the jig pin is supposed to have a length of 150mm (+/- 3mm) and a diameter of 3mm (- 0.03mm).Additionally, per the drawing, the proximal jig pin hole in the arm of the jig has a diameter of 3.15mm (+ 0.10mm, - 0.05mm).Upon dimensional testing of the returned jig pin, the diameter was determined to be 3.29mm.It also appears to have a threaded tip that has broken off, which has not been returned.Per the drawing, the proper jig pin does not have a threaded pin; instead, it has a trocar tip.Therefore, it is determined that the wrong jig pin was used.Once power was used to insert the jig pin through the bone, it became stuck to the instrument leading to the complaint description.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Without a lot number, the device history record review could not be requested.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 originally reported that an initial tibial plateau leveling osteotomy (tplo) procedure was performed on (b)(6) 2015.After the surgeon (veterinarian) inserted the pin into the bone through the tplo jig, the pin could not be backed out despite loosening the screw.Since the surgeon was unable to back the pin out, the decision was made to remove the jig and the pin as one unit.The procedure was successfully completed with no harm to the animal or surgical delay.Update: a visual inspection of the returned devices was conducted on february 9, 2016.At this time, it was discovered that the pin was actually broken.Additional outreach was then initiated; it was then reported that the surgeon cut the pin prior to removing the proximal portion of the pin and the tplo jig as one unit.The distal portion of the pin was removed from the animal without additional intervention.No fragments were left in the animal.This report is for one (1) unknown jig pin.This report is 1 of 1 for (b)(4).

• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5443619
• MDR Text Key: 38421077
• Report Number: 2520274-2016-11125
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/29/2015

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
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1