MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI DISTRACTION LOCK; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.125

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Date of postoperative device breakage is unknown.Unknown if the device was implanted during (b)(6) 2014 surgery or during october 18, 2017 surgery.Therapy date is either (b)(6) 2014 or (b)(6) 2017.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2014, the surgery for infant scoliosis was performed to fix the thoracolumbar by using the vertical expandable prosthetic titanium rib (vepter) system.Following continuous extension surgeries, a full extension surgery was performed on (b)(6) 2017.Around (b)(6) 2018, it was confirmed under the x-ray that the extension bar and rod had come off due to the possibility of the closure being detached.On (b)(6) 2018, during the planned revision surgery, part of these implants was confirmed to have been broken when extracted.The breakage occurred before the revision surgery.All the implants as well as the broken part were extracted and the revision surgery was successfully completed.There was no adverse consequence to the patient.Concomitant devices reported: ti rib sleeve-size 8 220mm radius (part # 497.107, lot # 7002855, quantity 1); ti lumbar extension size 8/220mm radius (part # 497.133, lot # 6032046, quantity 1); ti distraction lock (part # 497.125, lot # h243898, quantity 1).This report is for one (1) ti distraction lock.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Dhr review was completed.Product complaint #: (b)(4).Product investigation: (b)(4).Part number: 497.125.Lot number: h243898.Part manufacture date: 12-12-2016.Manufacture location: brandywine.Part expiration date: na.Nonconformance noted: na.Dhr record review: review of dhr revealed no complaint related anomalies.The dhr shows this lot of ti distraction lock - veptr was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to the complaint condition.Dhr review of raw material revealed this lot met all specification with no nonconformities noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.Us customer quality (cq) investigation workflow: broken.Visual inspection: visual inspection performed at customer quality of the returned distraction lock revealed the device was not broken.The device was received assembled to a rib sleeve (497.107/lot# 7002855).No major damage or deformation was observed.Minor nicks were observed that are consistent with implantation/explantation.Based on visual inspection, the condition of the device does not agree with the reported complaint description - the complaint condition was not confirmed, and no other failures were detected.Dimensional inspection: dimensional inspection of the distraction lock was not conducted as the complaint condition was not confirmed, and no other failures were detected.Document/specification review: device history record(s) showed that there were no issues during the manufacture of this product including the materials and its properties, which would contribute to this complaint condition.A relevant drawing review for the returned device was not performed as the complaint condition was not confirmed, and no other failures were detected.Conclusion: the complaint condition of the broken distraction lock was not confirmed; no malfunctions of the device were detected.There is no indication of a design or manufacturing defect as a result of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d10: date device returned to manufacturer.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

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Number of parts in complaint: ti rib sleeve-size 8 220mm radius (part # 497.107, lot # 7002855, quantity 1) is no longer considered to be concomitant.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

This is report 1 of 3 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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: TI DISTRACTION LOCK
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7574382
• MDR Text Key: 110342523
• Report Number: 8030965-2018-54150
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819747289
• UDI-Public: (01)07611819747289
• Combination Product (y/n): N
• PMA/PMN Number: K142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• 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: H243898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1