MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAMMERLOCK(TM) 2 IMPLANT KIT 15 X 5 MM, 1O DEGREES, MEDIUM; PIN,FIXATION,SMOOTH

Model Number HL2MA

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: investigation flow: device interaction/functional.Visual inspection: the hammerlock 2 implant kit (product code: hl2ma & lot number: bhl170769) was received at us cq for the investigation.Visual inspection of the returned device indicated that the inserter was broken prematurely and fully deployed the implant-tab assembly in the original sealed box.Functional test: a functional test was not performed as the complaint condition can be visually confirmed and the item was still in its original sealed package.Dimensional inspection a dimensional analysis was not performed because there is a known issue with the design of the device and a capa has been issued to address it.Document/specification review: this failure mode is a known issue with hl2 implant kits manufactured prior to corrective action implemented as part of capa (b)(4).Corrective actions (design and packaging design changes) identified within the capa were implemented via qcbd change order # 3853, released january 11, 2018.The complaint lot, lot# bhl170769, was manufactured in q4 2017 prior to the implementation of this corrective action.Conclusion: the overall complaint was confirmed as the implant has been deployed while still in its original packaging.Based on the investigation conducted, it has been determined that the most probable root cause for this type of complaint is the historical packaging/device design, with transit/handling being a contributing factor.The potential impact of the design in the complaint condition has already been addressed under the capa.No new product design issues or discrepancies were observed 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.No further action is recommended at this time.Device history lot: manufacturing location: supplier (b)(4), inspection and release by: monument, release to warehouse date(s): dec 13, 2017, quantities 49, 50 and 26 dec 22, 2017 quantity 48, expiration date: oct 17, 2022.Part number: hl2m, hammerlock 2 implant kit 15x5mm/0 degrees/medium, lot number: bhl170769 (non-sterile), lot quantity: 173 total (49, 50, 26 and 48).Nr-0086734 was initiated at op #20, incoming final inspection for two pieces that were found to have been deployed from the insertion stick.The disposition of the nr was rts two and release the remaining forty-eight pieces of that line item.Purchased finished goods travelers met all inspection acceptance criteria apart from the two pieces noted.Inspection sheets, incoming final inspection, ns071411 rev a met all inspection acceptance criteria (apart from the two pieces noted) with each lot 100% inspected for implant attachment to insertion stick.There are no certificates of conformance from biomedical enterprises included in any of these dhrs.This lot met all visual criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device history review: feb 21, 2020: dhr reviewed.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, during routine incoming inspection of loaner set it was observed that the hammerlock implant kit was damaged.There was no patient involvement.This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

• Brand Name: HAMMERLOCK(TM) 2 IMPLANT KIT 15 X 5 MM, 1O DEGREES, MEDIUM
• Type of Device: PIN,FIXATION,SMOOTH
• 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: 10033402
• MDR Text Key: 195256939
• Report Number: 2939274-2020-02285
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00810633021477
• UDI-Public: (01)00810633021477
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2020

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: 10/17/2022
• Device Model Number: HL2MA
• Device Catalogue Number: HL2MA
• Device Lot Number: BHL170769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/07/2020
• Date Device Manufactured: 12/22/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1