MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH TRIAL H 6MM 8DEG S; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	CET2860S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: exact date of event is unknown; event occurred in 2021 complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a depuy sales representative the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(4) reports an event as follows: it was reported during inspection it was detected that the device is broken.This report is for a trial.This is report 1 of 1 for (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.Visual inspection: the complaint device trial h 6mm 8deg s was returned to cq west chester for investigation.The returned trial was broken off at the junction of the head and the shaft where the cylindrical pin had been laser welded.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Dimensional inspection: complaint relevant dimension could not be measured due to damage.Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the trial was returned broken and it is not clear as to what resulted in the failure of the device.A definitive root cause was not determined during investigation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - product code #: cet2860s; synthes lot #: e19di1268; supplier: (b)(4); no ncrs were generated during production.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: TRIAL H 6MM 8DEG S
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: daniel seng ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 6103142063
• MDR Report Key: 13108296
• Report Number: 3013730328-2021-00066
• Device Sequence Number: 19621652
• Product Code: LXH
• UDI-Device Identifier: 04260397081600
• UDI-Public: (01)04260397081600
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K170503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CET2860S
• Device Catalogue Number: CET2860S
• Device Lot Number: E19DI1268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown