MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH QUICK COUPLING, SMALL; TAP,BONE

Catalog Number 311.43

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is company representative.Investigation summary: the handle with quick coupling, small (p/n 311.43 lot 7710142) was received with a vertical crack on the handle.The crack was across the location of the dowel pin and measured approximately 19.56 mm in length (calipers ca802).The instrument/handle was not separated into two pieces.No other issues were identified with the returned components of the device.Device failure/defect identified? yes: the device failure/defect of cracked handle was identified during investigation and is related to the reported complaint condition of broken.Dimensional inspection: a dimensional inspection was not performed during this investigation as the root cause of the device condition has been identified as a device design deficiency, which has subsequently been addressed through capa (b)(4).Document/specification review: the diameter and tolerance of bore hole in the handle was changed from ø4.4 mm +0/-0.05 mm to ø4.5 mm +0.05/-0 mm.Additionally, the diameter tolerance of the dowel pin hole in the handle was changed from ø2 mm +0/-0.3 mm to ø2 mm +0/-0.02 mm.These changes were made due to capa (b)(4) and are relevant to the device condition.Capa (b)(4) was launched on nov 03 2015 to identify the root cause of handle breakage and reduce its occurrence.Through the capa investigation, it was determined that the root cause of the handle cracking was that the tolerances of the holes in the handle were too tight.Depending on the material condition, the press fit between the metallic shaft/dowel pin and their corresponding holes in the handle could lead to an excessive interference fit condition, in which internal stresses within the handle are created.These internal stresses could lead to the handle cracking and/or breaking.The respective drawings were updated through action activity# (b)(4) and the design updates were deemed effective through effectiveness action# (b)(4).On (b)(4) determined the risk levels associated with a cracked complaint condition were low and medium and determined that an update to the risk documentation was required, which was done through capa (b)(4).The capa investigation determined that a new, limited scope dcrm would be created through action activity# (b)(4) to document the occurrence rates, severity levels and harms for device 311.43.The new dcrm (windchill# (b)(4)) was approved and released on 20 jan 2017.The reported complaint condition of broken is confirmed for the handle with quick coupling, small (p/n 311.43 lot 7710142) as the instrument was received with a vertical crack on the handle.The crack was across the location of the dowel pin and measured approximately 19.56 mm in length (calipers ca802).A valid design defect was identified as the root cause of the cracked condition.Capa (b)(4) was launched to address the design defect and was closed on 02 aug 2017 after effectiveness monitoring of the design changes was deemed effective.No manufacturing issues were identified through the investigation.A corrective and/or preventative action has already been launched and completed to address the design deficiency.See related action.Based upon these findings, no additional corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history review: part # 311.43.Synthes lot # 7710142.Supplier lot # na.Release to warehouse date: 02 jul 2014.Manufactured by synthes (b)(4).No ncr's were generated during production.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, the handle with quick coupling was broken.There was no patient involvement.This is report 1 of 1 for (b)(4).

• Brand Name: HANDLE WITH QUICK COUPLING, SMALL
• Type of Device: TAP,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8870974
• MDR Text Key: 154717527
• Report Number: 2939274-2019-59560
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187390
• UDI-Public: (01)10886982187390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.43
• Device Lot Number: 7710142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1