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 Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Occupation: initial reporter is synthes sales representative.The root cause of the issue was determined and previously addressed therefore further investigation including risk document review will not be performed on this complaint.Device history lot: part number: hl2la, bme lot number: bhl170557, manufacturing date or release to warehouse date: 1 sep 2017, place of manufacture: biomedical enterprises, (b)(4), lot expiration date: 08/15/2021.No ncmrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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.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 on an unknown date, the two (2) hammerlock 2 implant angled large boxes were damaged which could cause possible contamination of the implant.The hammerlock 2 implant large and hammerlock 2 implant small have come off the inserter.The speed titan compression implant broke through the unknown inserter.The packages of the speedarc compression implant and speedtraid implant sizing guide were damaged and could cause possible contamination.There was no patient involvement.Concomitant device reported: unknown inserter (part#: unknown, lot#: unknown, quantity#: 1).This report is for one (1) hammerlock 2 implant kit 15x7mm/10 degrees/large.This is report 1 of 3 for (b)(4).

• 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
• Manufacturer (Section G): SYNTHES BME : SAN ANTONIO; 14785 omicron drive; #205; san antonio TX 78245
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8420857
• MDR Text Key: 138808985
• Report Number: 2939274-2019-56953
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00810633021453
• UDI-Public: (01)00810633021453
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2021
• Device Model Number: HL2LA
• Device Catalogue Number: HL2LA
• Device Lot Number: BHL170557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1