MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM

Catalog Number 03.019.029

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is synthes sales consultant.A device history record (dhr) review was conducted: part: 03.019.029, lot: 8272860, manufacturing site: (b)(4), release to warehouse date: 14.Feb.2013.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Only top level of the device history record reviewed as sub-components are not lot tracked.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Visual inspection: visual inspection of the returned device performed at customer quality (cq) confirmed the condition of device breakage, which agrees with the reported complaint condition.The wire of the measuring probe has broken off the measuring body just distal to the laser weld.A small portion of the wire remains welded in the measuring probe sub-assembly.The broken off wire portion is also bent.The received condition does agree with the complaint description.Dhr review: the returned device was manufactured in february 2013 and is over 5 years old.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Only top level of the device history record reviewed as sub-components are not lot tracked.Document/specification review: the relevant design drawings were reviewed during this investigation.The 03.019.029 depth gage is a reusable instrument used to measure screw length for the multiloc humeral nails system.No product design issues or discrepancies were observed during this investigation.Dimensional inspection: the diameter of the wire near breakage measured and is within specification per wire for measuring head component design drawing.Material analysis: the design specified the wire component to be manufactured from 1.4441 material.A relevant material review could not be performed because only the top level of the device history record reviewed as sub-components are not lot tracked.There is no indication that material properties contributed to the returned 5 year old depth gauge breaking.This complaint is confirmed.Conclusion: a definitive root cause for the returned 5 year old device breaking could not be determined based on the provided information.The bent wire suggests that excessive unintended off-axis forces contributed to the wire bending and ultimately breaking.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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.

Event Description

It was reported that on (b)(6) 2018, the depth probe for multiloc humeral nailing system was used in an unknown case and was sent to the wash.When the set was opened, it was found out that device was broken.There was no patient involvement.This report is for one (1) depth probe for multiloc humeral nailing system.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM
• Type of Device: PROBE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8274875
• MDR Text Key: 134079642
• Report Number: 2939274-2019-56046
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10886982069696
• UDI-Public: (01)10886982069696
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.029
• Device Lot Number: 8272860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1