MAUDE Adverse Event Report: SYNTHES GMBH SPEED SHIFT 15X20X20 OFFSET 8MM IMPLANT; STAPLE, FIXATION, BONE

Model Number	SE-1520-08
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the implant was loose within the set, instead of being attached to the handle for insertion.The procedure was completed successfully with a five (5) minute delay using another implant.This report is for one (1) speed shift 15x20x20 offset 8mm implant.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.H3, h6: part #: se-1520-08, synthes lot #: bse171017, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 06mar2018, expiry date: 02 jan 2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the speedshift comp impl kit 15x20x20 ofst 8 (p/n: se-1520-08, lot #: bse171017) was returned and received at us customer quality (cq).Upon inspection of the returned device and the image provided under the pc attachment it was observed that all the components of the implant kit fell apart and were not assembled together.No other issues were identified with the returned device.Device failure/defect identified? yes.Functional test: a functional test could not be performed as all the components of the device fell apart.Can the complaint be replicated with the returned devices? unable to perform.Document/specification review implant inserter assembly speedshift:(current) speed shift staple: (manufactured) speed shift implant kit assembly: (manufactured).Dimensional inspection: a dimensional inspection was not performed as it was irrelevant to the complaint condition.Complaint confirmed? yes.Investigation conclusion the complaint condition could be confirmed for the returned device as the returned device was observed to have deformed retaining plates.There was no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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 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.H10: additional narrative: d4, d9, h4 h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.H11: corrected data: g1: physical manufacturer.

• Brand Name: SPEED SHIFT 15X20X20 OFFSET 8MM IMPLANT
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12191617
• Report Number: 8030965-2021-05889
• Device Sequence Number: 1480319
• Product Code: JDR
• UDI-Device Identifier: 00810633020432
• UDI-Public: 00810633020432
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 07/06/2021

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 Expiration Date: 01/02/2023
• Device Model Number: SE-1520-08
• Device Catalogue Number: SE-1520-08
• Device Lot Number: BSE171017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/27/2021; 09/03/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/24/2021; 09/28/2021
• Patient Sequence Number: 1