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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2019, during a decompression of first metatarsal (met) procedure, the surgeon noticed that the implant legs seemed compressed.He looked at the handle and noted that the slide on the inserter was half way pulled back.The surgeon tried to implant the device compressed by pulling it apart but could not get it to the work.He used another speed implant to finish the case.There were no fragments generated.Procedure was successfully completed with the delay of 10 minutes.There was no patient consequence.Concomitant device reported: unk - insertion handle (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This report is 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.Device history lot part number: se-181508trc, bme lot number: bse180104, manufacturing date or release to warehouse date: 13 mar 2018, place of manufacture: biomedical enterprises, san antonio, tx, lot expiration date: 5 feb 2023.A review of the device history record revealed there were complaint related anomalies during the manufacturing of this product.The device history record shows this lot of speed triad 18x15x08 mm 3-leg center was processed through the normal manufacturing and inspection operations with one nonconformance generated that could contribute to the complaint condition.Relevance to complaint condition cannot be determined until the product is returned for investigation.Device history review showed there were potential issues during the manufacture of the product that would contribute to this complaint condition.Relevance to complaint condition cannot be determined until the product is returned for investigation.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: 8418783
• Report Number: 2939274-2019-56944
• Device Sequence Number: 13913202
• Product Code: JDR
• UDI-Device Identifier: 00810633021613
• UDI-Public: (01)00810633021613
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 02/19/2019

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 Model Number: SE-181508TRC
• Device Catalogue Number: SE-181508TRC
• Device Lot Number: BSE180104
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/09/2019
• Patient Sequence Number: 1