MAUDE Adverse Event Report: SYNTHES BETTLACH UPPER SIDE ARM FOR PELVIC C-CLAMP II; TRACTION, COMPONENT, INVASIVE

Catalog Number 03.306.002

Device Problems Break (1069); Material Fragmentation (1261); Component Missing (2306); Detachment of Device or Device Component (2907)

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

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The lot number provided could not be verified, without a valid lot number the device history records review could not be completed.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

It was reported while using the upper side arm for pelvic c-clamp ii during a pelvic surgery where sacroiliac screws were being implanted, it was noted that one of the locking pins was missing from one of the pelvic c-clamp arms.The surgery was completed without any surgical delays as the device was still operable and still held on as expected without the pin.There was no impact to the surgery or to the patient.There was no additional medical intervention required and no surgical delays.The patient was noted to be stable at the end of surgery.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Clarification: the reported lot number, 2694705, was able to be verified.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.As previously reported, the subject device has been received and is currently in the evaluation process.Synthes manufacturing location was corrected.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received on march 20, 2016.It was further reported that half of the locking pin was found in the device and the other half of the locking pin was found in the graphics case prior to use on the patient.There were no fragments or pins retained in the patient.The date of the reported surgical procedure was (b)(6) 2016.

Manufacturer Narrative

A product investigation was completed: per the technique guide, the 03.306.002 upper side arm for pelvic c-clamp ii is an instrument routinely used in the pelvic c-clamp ii system along with the 03.306.000 inner rail for pelvic c-clamp ii, 03.306.001 outer rail for pelvic c-clamp ii for emergency stabilization for unstable injuries and fractures of the pelvic ring.The 03.306.002 upper side arm was returned and reported to be missing a pin from the locking mechanism area.This condition is confirmed; the pin/ sliding portion of the locking mechanism was not returned for the device.It is likely that the pin component was lost during sterile processing leading to this complaint condition.The 03.306.002 upper side arm was manufactured in february 2011 and is over 5 years old.The device is in fairly worn condition with several scrape and scuff marks along its length.The relevant drawings for the entire 03.306.010 assembly and upper arm were reviewed during this evaluation.The locking mechanism pin is pressed into place to secure.The design is determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned 03.306.002 upper side arm does agree with the complaint description.Unable to determine a definitive root cause.It is likely that the pin component was lost during sterile processing leading to this complaint condition.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.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: UPPER SIDE ARM FOR PELVIC C-CLAMP II
• Type of Device: TRACTION, COMPONENT, INVASIVE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5504782
• MDR Text Key: 40785160
• Report Number: 2520274-2016-11675
• Device Sequence Number: 1
• Product Code: JEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/29/2016

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: 03.306.002
• Device Lot Number: 2694705
• Other Device ID Number: (01)10886982077691(10)2694705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/05/2016; 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2011
• 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 Weight: 159