MAUDE Adverse Event Report: SYNTHES BRANDYWINE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE, DEPTH

Catalog Number 319.006

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2016

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, but has yet to be received.No service history review can be performed because the lot/serial number is unknown and cannot be traced.The manufacture date is unknown.The service history review is unconfirmed.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) 2016, a patient underwent a corrective osteotomy of the forearm for a mal-union due to previous fractures.There were no implants to be removed.While using the depth gauge, the surgeon complained that it was sticking.There was a thirty (30) second delay while another depth gauge was brought into the room.The patient was implanted with a minifrag locking compression plate (lcp) plate and four (4) screws.The remainder of the surgery was uneventful and the patient was reported as stable.After the surgery, the ball bearing of the device would not move when an attempt to clean the device was made.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (brand name depth gauge for 2.0mm and 2.4mm screws, part number 319.006, lot number a4hh936).The subject device was returned with the complaint condition stating the instrument was ¿sticking¿ during intraoperative use.This particular depth gauge is part of at least 14 technique guides, including the 2.4 mm variable angle lcp distal radius system and is used to measure the depth of the holes for the 2.0mm/2.4mm screws to ensure the correct screw length is used during the procedure.The information is provided per the 2.4 mm variable angle lcp distal radius system technique guide.Drawings for the subject device were reviewed.It was also found that the material of the handle was changed from radel to aluminum since the components required a sliding fit rather than an interference fit.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history record review was performed for the subject device lot number a4hh936.Manufacturing location: (b)(4).Date of manufacture: apr 28, 1998.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The device was received intact.The plastic handle is cracked, and the slider is severely worn.The wear on the slider and body does not cause the device to operate smoothly.There is too little resistance due to the ball being stuck and not providing any retention force.The hooked needle stem of the device is not broken off and is not bent.The device is also calibrated correctly.Although the exact cause cannot be determined, the most probable root cause for this complaint is wear from use and repeated sterilization cycles over the life of the device.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6056932
• MDR Text Key: 58454813
• Report Number: 2520274-2016-15073
• Device Sequence Number: 1
• Product Code: HTJ
• 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
• Type of Report: Initial,Followup
• Report Date: 10/05/2016

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 Catalogue Number: 319.006
• Device Lot Number: A4HH936
• Other Device ID Number: (01)10886982189943(10)A4HH936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/1998
• 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
• Patient Age: 7 YR