MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH COUGAR LS 21X14 15-DEG TRIAL; TEMPLATE

Model Number	287102814
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
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.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 reports an event in (b)(6) as follows: it was reported that the trial implant broke.No fragments were generated.Procedure was successfully completed with a ten (10) minute delay.There was no patient consequence.This report is for a cougar ls 21x14 15-deg trial implant.This report is 1 of 1 for (b)(4).
Event or Problem Description
This report is 1 of 2 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.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.Visual inspection: the cougar ls 21x14 15-deg trial (part # 287102814/ lot # pu65002) was received at us cq.The device broke at its weld just proximal to the trial spacer.It was clear that it was a weld failure as the inner male connecting piece was not damaged.The received condition was consistent with the complaint condition thus the complaint was confirmed.Device failure/defect identified? yes; weld failed leading to device breakage.Dimensional inspection: specified dimensions: shaft outer diameter = 6.35mm +/- 0.2mm.Male connecting shaft outer diameter = 3.175mm + 0.025mm / - 0.00mm.Female connecting hole inner diameter = 3.2mm +/- 0.012mm.Measured dimensions: shaft outer diameter = 6.35mm; conforming (measured w/ ca215p).Male connecting shaft outer diameter = 3.175mm; conforming.Female connecting hole inner diameter = 3.19mm; conforming.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).Conclusion: the overall complaint was confirmed for the received cougar ls 21x14 15-deg trial as the weld connecting the shaft to the trial spacer failed.Although no definitive root-cause can be determined its possible the device experienced unintended forces while in use leading to weld failure.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: a review of the receiving inspection (ri) for cougar ls 21x14 15-deg trial was conducted identifying that lot number pu65002 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 12 sep 2012 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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
Product complaint # (b)(4).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.D11: concomitant device reported: unknown other products (part# unknown, lot# unknown, quantity 4); unknown other products (part# unknown, lot# unknown, quantity 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.
Event or Problem Description
Device report from synthes reports an event in switzerland as follows: it was reported that the trial implant broke.No fragments were generated.Procedure was successfully completed with a ten (10) minute delay.There was no patient consequence.This report is for a cougar ls 21x14 15-deg trial implant.Unknown other products (part# unknown, lot# unknown, quantity 4); unknown other products (part# unknown, lot# unknown, quantity 4).

• Brand Name: COUGAR LS 21X14 15-DEG TRIAL
• Common Device Name: TEMPLATE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9659079
• Report Number: 1526439-2020-00484
• Device Sequence Number: 14288180
• Product Code: HWT
• UDI-Device Identifier: 10705034359908
• UDI-Public: (01)10705034359908
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 01/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 287102814
• Device Catalogue Number: 287102814
• Device Lot Number: PU65002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/13/2020; 04/22/2020; 04/24/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/03/2020; 04/22/2020; 04/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: QUANTITY 4; QUANTITY 4