MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAMMERLOCK 2 IMPLANT KIT 15X7MM/0 DEGREES/LARGE; INTRAMEDULLARY BONE FASTENER

Model Number	HL2L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.Visual inspection: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 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: hl2l, bme lot number: bmehl160325, manufacturing date or release to warehouse date: 12 oct 2016, place of manufacture: biomedical enterprises, (b)(4), lot expiration date: 16 sep 2021.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of hammerlock 2 large implants was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.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.Lot 1605125089 was released as conforming as all nonconforming parts were scrapped.The nonconformance is not relevant to the complaint because cosmetic issues on the implants would not contribute to the inserter breaking and deploying the implant prematurely.This raw material lot met all dimensional and visual criteria at the time of release with no issues documented that would contribute to this complaint condition.Nonconformance is not relevant to the complaint because cosmetic issues on the implants would not contribute to the inserter breaking and deploying the implant prematurely.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 speedtitan 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 medical products reported: unknown inserter (part#: unknown, lot#: unknown, quantity#: 1) this report is for one (1) hamm.Rlock 2 implant kit 15x7mm/10 degrees/large.This is report 2 of 3 for (b)(4).

• Brand Name: HAMMERLOCK 2 IMPLANT KIT 15X7MM/0 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: 8420736
• Report Number: 2939274-2019-56955
• Device Sequence Number: 10832254
• Product Code: HTY
• UDI-Device Identifier: 00810633021446
• UDI-Public: (01)00810633021446
• 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: 09/16/2021
• Device Model Number: HL2L
• Device Catalogue Number: HL2L
• Device Lot Number: BMEHL160325
• 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