MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAMMERLOCK 2 IMPLANT KIT 15X7MM/0 DEGREES/LARGE; PIN, FIXATION, SMOOTH

Model Number HL2L

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

Patient id also reported as (b)(6).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.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 during a metatarsophalangeal joint arthrodesis on (b)(6) 2019, an expired hammerlock 2 implant kit was implanted in the patient.The issue was discovered when the circulating nurse looked at the sticker from the implant just before the patient woke up and realized that it was out of date.The surgeon immediately removed the hammer lock implant and replaced it with a hammertoe correction k-wire.He did not implant another hammer lock.The procedure was successfully completed with 15 minutes surgical delay.Patient was good.Concomitant devices: drill kit for hammer lock implant (part: dk-h2, lot: bdk180839, quantity: 1).This report is for a hammerlock 2 implant kit.This is report 1 of 1 for (b)(4).

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.Part: hl2l bme lot: bmehl145085b manufacturing date or release to warehouse date: october 22, 2014 place of manufacture: biomedical enterprises, san antonio, tx lot expiration date: october 31, 2019 dhr review: a manufacturing record evaluation was performed for the finished device lot# bmehl145085b and no nonconformances or manufacturing irregularities related to the complaint condition were identified.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.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could not be confirmed.However, upon reviewing the device history record (dhr) and the surgery date, it can be confirmed that the device was used beyond its labelled expiration date.Lot expiration date: oct-2019 surgery date: dec-2019 since the device was not returned, a dimensional inspection and a functional test were not able to be performed.No definitive root cause could be determined.However, it is possible due to an user error per the event description.During the investigation, no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: HAMMERLOCK 2 IMPLANT KIT 15X7MM/0 DEGREES/LARGE
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9670880
• MDR Text Key: 178205052
• Report Number: 2939274-2020-00640
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00810633021446
• UDI-Public: (01)00810633021446
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: HL2L
• Device Catalogue Number: HL2L
• Device Lot Number: BMEHL145085B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/06/2020
• Patient Sequence Number: 1
• Treatment: HAMMERLOCK 2 DRILL KIT WITH 2.1MM DRILL BIT
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 118