MAUDE Adverse Event Report: UMKIRCH SHAFT F/TRIAL IMPLANTS H5; TEMPLATE

Catalog Number 03.820.279

Device Problems Break (1069); Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.(b)(6).510k: device is not distributed in the united states, but is similar to device marketed in the usa.A device history record (dhr) review was performed on part number: 03.820.279, lot number: 8386403: manufacturing site: (b)(4), manufacturing date: 24.April 2016: no non conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development investigation was performed.The trial implant was not returned for investigation.The shaft for the trial implant was returned and was found to have broken distal threads.There are segments missing from the threads.The proximal coupling also has some minor deformation likely due to connection to the handle.No other issues were noted.A visual inspection, drawing review and device history record (dhr) review were performed as part of this investigation.The complaint is confirmed, based on the damage to the distal threads.Replication was not possible, as the trial spacer was not returned.Pictures of the trial implant medium deep-5mm were sent for review.Pictures of the device do not show any damage.No issues were observed that would contribute to the complaint condition.The damage to the trial implant shaft would likely lead to the reported complaint condition.Relevant drawings were reviewed during investigation.The design history was not found to impact the complaint condition.No definitive root cause was able to be determined.It is possible that the threads broke due to cross threading or rough handling during use.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.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 reports an event in (b)(6) as follows: it was reported that during a demonstration of the devices on an unknown date, the nurse identified that the prodisc-c nova trial implant medium deep 5mm and shaft for trial implants h5 will not properly attach together, perhaps the threads are damaged.A second shaft for trial implants h5 was tried with the trial implant medium deep 5mm and it fit with no difficulties and worked as it should.There is visible physical damage to the shaft but the trial seems perfect.No patient involvement.During manufacturer investigation it was identified that the returned shaft for the trial implant has broken distal threads.There are segments missing from the threads.This condition was re-evaluated and determined to be reportable on april 28, 2017.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Please disregard the previous follow-up ((b)(4)) 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

Date returned to manufacturer.Subject device has been received and a dhr and updated investigation was performed.Dhr review: part # 03.820.232, lot # 7974965, manufacturing site: (b)(4), manufacturing date: 20.July 2012.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Updated based on pictures of part # 03.820.232, lot # 7974965; pictures of the trial implant medium deep-5 mm were sent for review.The following drawings were reviewed during investigation.Trial implant shaft - se_244782 rev b, trial implant md - 5 mm - se_200815 rev c/d.Updated investigation was performed.The investigation of the complaint articles has shown that: the design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.Canada reported the following event: during a demonstration of the devices on an unknown date, the nurse identified that the prodisc-c nova trial implant medium deep 5 mm and shaft for trial implants h5 will not properly attach together, perhaps the threads are damaged.No patient involvement.Update 23mar2017 - a second shaft for trial implants h5 was tried with the trial implant medium deep 5 mm and it fit with no difficulties and worked as it should.There is visible physical damage to the shaft but the trial seems perfect.The shaft for the trial implant was returned and was found to have broken distal threads.There are segments missing from the threads.The proximal coupling also has some minor deformation likely due to connection to the handle.Replication is not relevant as the threads on the shaft for trial implant are broken.Updated based on pictures of part # 03.820.232, lot # 7974965; pictures of the trial implant medium deep-5 mm were sent for review.Inspection of the returned device part # 03.820.232, lot # 7974965 did not reveal any additional malfunctions.No definitive root cause was able to be determined.It is possible that the threads broke due to cross threading or rough handling during use.Inspection of the returned device part # 03.820.232, lot # 7974965 did not reveal any additional malfunctions.No dcrm calculation will be performed for this complaint.No other issues were noted.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: SHAFT F/TRIAL IMPLANTS H5
• Type of Device: TEMPLATE
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer (Section G): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6552216
• MDR Text Key: 74891256
• Report Number: 3003862213-2017-10015
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 07611819415225
• UDI-Public: (01)07611819415225(10)8386403
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.820.279
• Device Lot Number: 8386403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2016
• 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