MAUDE Adverse Event Report: SYNTHES (USA) 4.9MM TI LOCKING BOLT 42MM; PIN, FIXATION, SMOOTH

Catalog Number 459.420

Device Problem Failure to Align (2522)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is unknown.(b)(4).Complainant part is not going to be returned concomitant medical devices: blade (unknown part #, unknown lot #, quantity of 1); aiming arm (unknown part #, unknown lot #, quantity of 1); insertion handle: (unknown part #, unknown lot #, quantity of 1).(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the usa.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.Based on the complaint description, without material, no further investigation is possible.Per dhr review of the known lot numbers were the parts manufactured according to the specification.We can only declare that for the products 472.265s and 459.420 we use only raw material which corresponds the astm f1295 specification and the international standards iso 5832-11.The article 472.265s with lot no 9099385 was manufactured in a quantity of (b)(4) pieces on august 2014.We are not aware of any quality problems or failures caused by a faulty product on the article.Also we are not aware of any other complaint for this article- and lot number combination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in australia as follows: it was reported by the surgeon that a 4.9 locking bolt missed the aperture in the nail.This was discovered on (b)(6) 2016 during post-op lateral view x-rays that were taken 3 days after proximal femoral nail antirotation (pfna) surgery.In the surgeon¿s opinion, he states that this probably occurred due to the small diameter of nail which was too small for the patient¿s anatomy.In addition, excessive force may have been placed on insertion handle/aiming arm during drilling of distal locking bolt causing drill and locking bolt to skive and miss the nail.Original implant date occurred on (b)(6) 2016.Surgeon revised the nail successfully on (b)(6) 2016.Concomitant medical devices reported: blade (unknown part #, unknown lot #, quantity of 1); aiming arm (unknown part #, unknown lot #, quantity of 1); insertion handle: (unknown part #, unknown lot #, quantity of 1).This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Date of event: unknown.(b)(4).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: 4.9MM TI LOCKING BOLT 42MM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 5726676
• MDR Text Key: 47454121
• Report Number: 2520274-2016-13174
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 459.420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention