MAUDE Adverse Event Report: SYNTHES (USA) O-RING F/392.901; TRACTION, APPARATUS, NON-POWERED

Catalog Number 392.925

Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problem Failure of Implant (1924)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Unknown.Patient age was reported as between 9 and 13 years.(b)(4).The exact date of implant is unknown and was approximately (b)(6) 2016.(b)(6).The 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The subject device has been received and is currently in the evaluation process.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 (b)(6) as follows: it was reported that the central body for the monolateral external fixation system for trauma and orthopedics (mefisto) does not elongate the area where the disk and the dynamization parts are.The external fixator (mefisto system) was placed six days prior to (b)(6) 2016.The reported issue was observed on (b)(6) 2016; on the sixth day of the elongation treatment.The surgeon turned on the disc hole to test the elongation function but it appeared that the system (o-ring) is blocked and cannot rotate.The mefisto system was removed on (b)(6) 2016 due to the central body's inability to perform elongation.This report is 2 of 3 for com-(b)(4).

Manufacturer Narrative

Manufacturing investigation evaluation: one (1) article of central body f/mef max-l 437 min-l 287 (part 392.901) was received for manufacturing investigation.The article is in a used condition with visible marks of use at the anodized end parts.The department responsible for the assembly and testing of the central body f/mef has evaluated the complained issue.The investigation was to determine if the issue, as it was reported, could be found when manipulating the movable parts.The exact malfunction could not be duplicated during the tests.However, the following anomalies were found: the subcomponent dynamization end piece (part 392.901.013) was making noise and an abnormal type of resistance was felt when turning on it.Also, damages on the o-ring seal, residues on the outer thread, and discoloration of the wrench surface were observed.It is likely that the residue came into the mechanism of the dynamization end piece as a result of insufficient cleaning and reprocessing.No manufacturing related issues were identified and/or confirmed.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.

• Brand Name: O-RING F/392.901
• Type of Device: TRACTION, APPARATUS, NON-POWERED
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5485754
• MDR Text Key: 39864073
• Report Number: 2520274-2016-11524
• Device Sequence Number: 1
• Product Code: HST
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 392.925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention