MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 90 DEG TI S-HOOK/RIGHT; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.601.000

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Date of postoperative hook breakage is unknown.Implanted couple of months ago; exact date is unknown.Explant date is unknown.Reporter¿s phone number is not provided for reporting.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 an ala-hook was broken in a patient who was operated with vertical expandable prosthetic titanium rib ii (veptr ii) a couple of months ago.New ala hook is ordered and revision surgery was performed successfully on an unknown date.The broken device was removed easily during the revision surgery.This report is for one (1) 90 degree ti s-hook/right.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Part: 04.601.000; lot: 9882240; date of manufacture: september 09, 2015; place of manufacture: rms / (b)(6); part expiration date: none; list of nonconformances: none description of dhr review: no nonconformance reports (ncrs) were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.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 action.Investigation flow: broken.Visual inspection: visual inspection of the returned device performed at customer quality (cq) confirmed the condition of post-operative breakage which agrees with the reported complaint condition.The returned vertical expandable prosthetic titanium rib (veptr) 90-degree s-hook right implant was received in two pieces.The break is slightly oblique and is located approximately 13mm from the non-pointed end.The material surfaces at the fracture site appear homogeneous with no voids or abnormalities observed when viewed under 10x magnification at cq.Document/specification review: the returned device was manufactured in september 2015.No ncrs were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.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 action.Design drawing was reviewed during this investigation.The 90-degree titanium s-hook right is a component of the veptr ii system instrument and implant set.The veptr ii is 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.No product design issues or discrepancies were observed.Risk documentation: the veptr design and clinical risk management (dcrm) document covers the returned s-hook and addresses the hazard of s-hook may break during surgery or post operatively.Based on the contents of the associated dcrm the complaint condition is adequately addressed and the calculated occurrence rate does not exceed established limits.Dimensional inspection: the shaft diameter of the returned device at location of breakage measured ø4.97mm at cq (calipers ca592) which is within specification of ø5.00mm +0/-0.05mm per design drawing.Material analysis: the design specifies the device is to be manufactured from titanium (grade 4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Conclusion: a definitive root cause doe the device breaking postoperatively could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation and the calculated occurrence rate does not exceed established limits.No new, unique or different patient harms were identified as a result of this evaluation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Physical 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.Device manufacture date.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: 90 DEG TI S-HOOK/RIGHT
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7648709
• MDR Text Key: 112704260
• Report Number: 8030965-2018-54711
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819868601
• UDI-Public: (01)07611819868601
• 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
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.601.000
• Device Lot Number: 9882240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 08/29/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention