MAUDE Adverse Event Report: DEPUY SPINE INC IMPACTOR

Model Number	TET30200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition be confirmed the shaft is broken into two or more pieces.No other issue(s) was identified with the device.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot.Part # tet30200, synthes lot # e15di0112, supplier lot # e15di0112, release to warehouse date: sep 03, 2015, supplier: (b)(6), no ncr's were generated during production.Device history review.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that it was discovered before the surgery that the cage impactor was broken.It was unknown how, when its happened.There was no surgery reported.There were no patient consequences.This complaint involves one (1) device.This report is for (1) mmsi driver shaft for red screw.This is report 1 of 1 (b)(4).
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: h4 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.
Additional 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: updated data: h6.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.
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary visual inspection: the eit tlif impactor (part #: tet30200, lot #: e15di0112) was received at us cq.Upon visual inspection, it was noticed that the distal tip of the impactor has deformation in the corners where the tip was attached to the rod.No other issues were identified with the device.Device failure/defect identified? yes.Dimensional inspection: width of the tip: measured: print dimensions: result: conforming diameter of the rod: measured: print dimensions: result: conforming.Document/specification review: the following drawings were reviewed.Tet30200 tlif impactor: (manufactured and current) tet30200-01 eit tlif impactor rod: (manufactured and current) complaint confirmed? no.Conclusion: the complaint condition is not confirmed for the reported condition of tlif impactor (part #: tet30200, lot #: e15di0112).However, there is slight deformation at the corners of the tip where the tip is attached to the impactor rod.While no definitive root cause could be determined, it is possible the device encountered unintended forces during its use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

• Brand Name: IMPACTOR
• Common Device Name: IMPACTOR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10442450
• Report Number: 1526439-2020-01505
• Device Sequence Number: 14446774
• Product Code: HWA
• UDI-Device Identifier: 04260397081440
• UDI-Public: (01)04260397081440
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TET30200
• Device Catalogue Number: TET30200
• Device Lot Number: E15DI0112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 08/26/2020; 09/21/2020; 10/20/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/21/2020; 10/16/2020; 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1