MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CHRONOS(TM) BETA-TCP STRIP 100MM X 25MM X 3MM-STERILE

Model Number	07.801.101.99S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.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.(b)(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
It was reported that on an unknown date, the chronos beta tcp strip caused a post-operative infection.The reported device was implanted on (b)(6) 2018.The issue was discovered during a post-op visit.Patient consequence is unknown.This report involves one (1) chronos (tm) beta-tcp strip 100mm x 25mm x 3mm-sterile.This is report 1 of 1 for (b)(4).This product complaint is related to (b)(4), which captures the reported event involving patient two (2) with chronos strip lot ds700911, implanted on (b)(6) 2019.This report is for (b)(4) and will capture the event involving patient one (1) with chronos strip lot # dse8043, implanted on (b)(6) 2018.
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, h4, h6- product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot manufacturing location: supplier - (b)(4) and released by: monument, release to warehouse date: 06-feb-2018, expiration date: 28-dec-2019, part number: 07.801.101.99s, chronos (tm) beta-tcp strip 100mm x 25mm x 3mm ¿ sterile, lot number: dse8043 (sterile).This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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: CHRONOS(TM) BETA-TCP STRIP 100MM X 25MM X 3MM-STERILE
• Common Device Name: CHRONOS(TM) BETA-TCP STRIP 100MM X 25MM X 3MM-STERILE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9977972
• Report Number: 2939274-2020-01928
• Device Sequence Number: 14276874
• Product Code: MQV
• UDI-Device Identifier: 10705034753706
• UDI-Public: (01)10705034753706
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2019
• Device Model Number: 07.801.101.99S
• Device Catalogue Number: 07.801.101.99S
• Device Lot Number: DSE8043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/07/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 61