MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation.Concomitant medical products: unknown synthes reamer head, (b)(6) 2017.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2017, a revision surgery involving hardware removal was performed to treat nonunion of a humeral shaft fracture.The original procedure was performed on an unknown date during which the patient was implanted with synthes devices.Subsequently it was determined that there was nonunion.During the revision procedure, as a flexible reamer was being used to widen the canal, the flexible reamer shaft would not hold on to various reamer head sizes.The reamer heads would just slide off and would not catch on to the shaft.The reamer shaft appeared to be worn.Another reamer shaft was available for use.There was no malfunction associated with reamer heads.There was no reported surgical delay.Removed hardware included: one (1) six-hole broad plate and six (6) 5.0 mm locking screws.All explanted devices were found to be intact.The patient was revised to a new 8-hole broad plate, screws and a fibular allograft.Nothing untoward occurred during this procedure.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: unknown synthes reamer head.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A device history record review was performed for the subject device lot number 2089471.Manufacturing location: (b)(4).Date of manufacture: 25.Feb.2004 the review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformance's were generated during the production of the subject device.A product development investigation was performed for the subject device (flexible shaft, part number 352.040, lot number 2089471).The subject device was returned with the complaint condition stating there was superficial signs of routine use, and the prongs of its distal tip were found to be slightly bent inward, which could have contributed to the complaint condition and therefore confirmed it and made its replication inapplicable.As part of this investigation a visual inspection, drawing review, and root cause analysis were performed.Drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.No mrrs, ncrs, or actions related to the complaint condition were generated during production of the returned part(s).Review of device history record(s) showed that there were no issues during the manufacture of the product(s), which would contribute to the complaint condition.The material, material properties, and hardness of the returned part(s) were determined to be conforming at the time of manufacture and based on review of the associated/available dhr(s) and based on the details of the complaint and investigation of the returned part(s), additional material/hardness testing is not required.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the available information it is not possible to determine a definitive root cause for the complaint condition.The flexible reamers for intramedullary nails technique guide states that the reaming rod must be held in place to secure the reduction head during reaming.It is possible that if a reaming rod was not adequately held in place during reaming that it could agitate connected reamer heads and contribute to them detaching from the distal tips of shafts.It is also stated that the user should not rotate the reamer head when inserting it into the medullary canal, should use the highest speed and slight but uniform force to advance the reamer, and move the shaft back and forth to remove bone chips to prevent jamming of the reamer head.If the recommended guidance was not followed as intended, it could have contributed to the complaint condition.It is also possible that rough usage and/or processing could have caused the prongs on the distal tip of the shaft to bend inwards, which would also prevent reamer heads from remaining secured onto the distal tip of the returned shaft.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BETTLACH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7042641
• MDR Text Key: 93453237
• Report Number: 2939274-2017-50011
• Device Sequence Number: 1
• Product Code: HTO
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Device Lot Number: 2089471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2004
• 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