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

Model Number	HL2LA
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: INTRAMEDULLARY BONE FASTENER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8420857
• Report Number: 2939274-2019-56953
• Device Sequence Number: 11344806
• Product Code: HTY
• UDI-Device Identifier: 00810633021453
• UDI-Public: (01)00810633021453
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K133520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/14/2019
• Patient Sequence Number: 1