MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAMMERLOCK 2 IMPLANT KIT 15X7MM/10 DEGREES/LARGE; INTRAMEDULLARY BONE FASTENER

Model Number HL2LA

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.It is unknown when device malfunctioned.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.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 Description

It was reported that when sales consultant was going through the inventory on (b)(6) 2018 it was identified that one (1) hammerlock implant kit and one (1) speedarc compression implant kit (non-implanted stock) still sterile packaged were broken.Devices are still packaged and not opened.There was no patient and procedure involvement.This report is for one (1) hammerlock 2 implant kit 15x7mm/10 degrees/large.This is report 1 of 2 for complaint (b)(4).

Event Description

Update,10.12.2018: the devices involved in this complaint were received by bme on oct.12, 2018.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: update information.The device was 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.

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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device history device history lot part number: hl2la, bme lot number: bhl170040, manufacturing date or release to warehouse date: 10 mar 2017, place of manufacture: biomedical enterprises, san antonio, tx, lot expiration date: 1 feb 2022.Dhr review: 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 hl2la implants was processed through the normal manufacturing and inspection operations with one non-conformance generated that could contribute to the complaint condition.Was generated due to thirty (30) implant kits with broken inserters found post-sterilization.Lot bhl170040 was released as conforming as all nonconforming items were scrapped.Relevance to complaint condition cannot be determined until the product is returned for investigation.Device history review dhr 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.Investigation summary complaint condition: it was reported on (b)(6) 2018, two (2) hammerlock implant kit were defective.It is unknown when the issue was discovered.It is unknown if there was patient and procedure involvement.The hammerlock 2 implant kit (part # hl2la, lot # bhl170040, mfg # 10 mar 2017) was received at us cq and sent for manufacturing evaluation at bme.The results of the manufacturing evaluation are as follows: visual inspection was performed to determine the failure mode of this complaint.Inspection showed that the inserter broke, releasing the implant-tab assembly, confirming the complaint condition.Performed (b)(6) 2018.The items involved in this complaint are part of the bounding.Items were 100% compliant with bme requirements at the moment of release.After investigation, it was determined that the root cause was a molding issue from the provider (protolabs).No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not required.The potential impact of the design in the complaint condition is currently being addressed.Conclusion: the complaint condition is confirmed as the hammerlock 2 implant kit (part # hl2la, lot # bhl170040) is broken.Replication of the complaint condition is not applicable as the inserter is already broken.A root cause could not be definitively determined.No manufacturing related issue was identified and/or confirmed.Thus, all further investigations and actions, including assessment of risk, corrective and/or preventative action is proposed or already launched.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.

• Brand Name: HAMMERLOCK 2 IMPLANT KIT 15X7MM/10 DEGREES/LARGE
• Type of Device: INTRAMEDULLARY BONE FASTENER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7984981
• MDR Text Key: 124548672
• Report Number: 2939274-2018-54486
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00810633021453
• UDI-Public: (01)00810633021453
• Combination Product (y/n): N
• PMA/PMN Number: K133520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: HL2LA
• Device Catalogue Number: HL2LA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 11/20/2018
• Patient Sequence Number: 1