MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH OPAL IMPL-HOLDER; MISC ORTHO SURGICAL INSTR

Catalog Number	03.803.001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an unknown procedure, the screw that was part of the opal implant holder fell out.A second implant holder was available to complete the surgery.The procedure was successfully completed with approximately 10 minutes surgical delay.There was no other medical intervention required.There was no patient consequence.This report is for one (1) opal implant holder straight.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.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
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: h3, h6: a product investigation was conducted.Visual inspection: the received opal implant holder head is in a used condition with some scratches and marks at the top.One holding screw is solved.The whole opal implant holder was not returned for further investigation.Function test: a functional test cannot have performed as the main part is missing, not returned for investigation.Dimensional inspection: not required per selected investigation flow as root cause is use related.Drawing/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the article, therefore no drawing/specification review is needed.Summary: due the solved holding screw at the opal implant holder head, the complaint condition is rated as confirmed.Unfortunately, we only have limited information in the complaint description and cannot determine how it got solved.Also the whole opal implant holder was not received for further investigation.We only can assume that the complaint condition occurred due to incorrect handling at the cleaning process or on a previous surgery.Therefore, we conclude that the cause of failure is not due to any manufacturing non-conformances.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: OPAL IMPL-HOLDER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8281886
• Report Number: 8030965-2019-60421
• Device Sequence Number: 11071189
• Product Code: LXH
• UDI-Device Identifier: 07611819940598
• UDI-Public: (01)07611819940598
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2019

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 Catalogue Number: 03.803.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 02/07/2019; 03/15/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/01/2019; 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1