MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDTRIAD COMPRESSION IMPLANT KIT 18X15X8MM CENTERED; BONE STAPLE

Model Number	SE-181508TRC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's height reported as 6 feet 2 inches.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.
Event or Problem Description
It was reported that the inserter handle broke as the triad implant was being inserted on (b)(6) 2019.Fragments were generated but easily removed.There was a surgical delay of ten (10) minutes.Procedure was successfully completed.There was no patient harm. patient outcome reported as good.This report is for one (1) speedtriad compression implant kit 18x15x8mm centered.This is report 1 of 1 for complaint (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.Part: se-181508trc; bme lot: bse180438; manufacturing date or release to warehouse date: june 08, 2018; place of manufacture: biomedical enterprises, san antonio, tx; lot expiration date: may 01, 2023.The device history record (dhr) for lot bse180438 was reviewed and revealed no complaint related anomalies.The device history record shows this lot of centered speed triad implant kits was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The review of the raw material device history records revealed no complaint related anomalies: the raw material insertion stick lots used in assembly of bse180438 were received, and review identified these lots met all dimensional & visual acceptance criteria with no rework or nonconformities.The raw material speed triad center 18x15x08mm implants used in assembly of bse180438 were manufactured as lots 1803127041, 1803127042, & 1803127043 and review identified these lots.Visual inspection: visual inspection was performed to determine the failure mode of this complaint.Inspection showed that the inserter broke at the bottom on the island feature, confirming a broken condition of the inserter.Dimensional inspection dimensional inspections were performed on both the inserter and the implant, with both being within the acceptable requirements.Document/specification review drawings were reviewed during investigation.The potential impact of the design in the complaint condition is being addressed.Conclusion: the complaint was confirmed with investigation.Dhr review showed there were no manufacturing related nonconformities that could¿ve contributed to this complaint condition.There is no indication of damage to the inserter that could contribute to the breakage, therefore the complaint root cause cannot be determined based on the results of the product evaluation and the information provided on the complaint.No manufacturing related issue was identified and/or confirmed.The potential impact of the design in the complaint condition is being addressed.No further corrective action is considered necessary at this time.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: SPEEDTRIAD COMPRESSION IMPLANT KIT 18X15X8MM CENTERED
• Common Device Name: BONE STAPLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8573999
• Report Number: 2939274-2019-57775
• Device Sequence Number: 2172823
• Product Code: JDR
• UDI-Device Identifier: 00810633021613
• UDI-Public: (01)00810633021613
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K133844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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 Expiration Date: 05/01/2023
• Device Model Number: SE-181508TRC
• Device Catalogue Number: SE-181508TRC
• Device Lot Number: BSE180438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/03/2019
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 82