MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI DISTRACTION LOCK; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.125

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Original implant date is unknown, sometime in (b)(6) 2015.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: dhr review request: manufacturing date: 03-aug-2015, p/n 497.125, lot # 9860906 did not contain any ncr or anomalies.Total lot pcs was 50, all 10 were accepted.The following rm lots #s were reviewed 9860906, dhr records for the raw material lot further indicate that the raw material underwent all required inspection and test requirements with no nonconformities reported.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported patient was implanted with a veptr ii rib to rib construct on an unknown date in (b)(6) 2015.Patient was returned to surgery on (b)(6) 2016 for an extension of that construct as part of the treatment plan.During the lengthening procedure it was noted that the distraction lock on the rib to rib construct was dislodged and was no longer on the construct.Some subsidence was noted since the previous lengthening procedure completed in (b)(6) 2015.Distraction lock was initially implanted to connect the proximal and distal extensions.It is not known what levels are involved.Concomitant devices reported: proximal extension (part and lot number unknown, quantity 1), distal extension (part and lot number unknown, quantity 1).This report is 1 of 1 for (b)(4).

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.

Manufacturer Narrative

Additional narrative: clarification: although post-operative migration of an implanted device was reported, the discovery of the issue was made during a planned extension procedure.No additional medical intervention outside of the scheduled treatment plan was needed.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.

Manufacturer Narrative

Product investigation was completed.One ti distraction lock was returned to manufacturer for investigation.A visual inspection, device history records review, and drawing review were performed as part of this investigation.The returned device was examined and no identifiable defects or deficiencies were noted which may have contributed to the complaint condition.Minor witness marks consistent with implantation and explantation were noted.As no medical imaging was provided, there is no way to confirm the complaint.A device history review was performed for the returned instrument¿s lot number and no materials records review, non conformance reports or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture).The design, materials and finishing processes were found to be appropriate for the intended use of this device.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No product design issues or discrepancies were observed.The distraction lock (497.125) is a component of the veptr (vertical expandable prosthetic titanium rib) and veptr ii systems which are utilized to ¿mechanically stabilize and distract the thorax to correct three-dimensional thoracic deformities and provide improvement in volume for respiration and lung growth in infantile and juvenile patients diagnosed with or at risk of developing thoracic insufficiency syndrome.¿ the distraction lock is specifically utilized to connect the rib sleeve to the superior cradle, inferior cradle or lumbar extension (veptr) or to connect the rib hook cap, rib hook to the rib hook extension, proximal extension to distal extension and veptr adapter to veptr device cradle (veptr ii).No root cause was able to be determined as the complaint condition was unable to be 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: TI DISTRACTION LOCK
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5884198
• MDR Text Key: 52384571
• Report Number: 1719045-2016-10617
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142587
• 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,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.125
• Device Lot Number: 9860906
• Other Device ID Number: (01)10705034787480(10)9860906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1