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

Catalog Number 319.006

Device Problem Sticking (1597)

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

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient id and weight are unknown.Patient age reported as between 16 and 25 years old.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Manufacturing location: (b)(4) assembly.Manufacturing date: 22 february 2000.Part: 319.006, lot : 4070014 (non-sterile) - depth gauge for 2.0mm and 2.4mm screws.Lot was release to the warehouse on 22 february 2000.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 the depth gauge is not sliding easily during an olecranon procedure.It is getting stuck, making it difficult to get an accurate screw length reading.It was soaked in water to help it slide but that did not work.Plate benders from another set were used.This was not a revision procedure.Another part was available to complete the surgery and there was no delay in surgery.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: the depth gauge (319.006 / lot 4070014) was returned with the complaint description: ¿¿the depth gauge is not sliding easily.It is getting stuck, making it difficult to get an accurate screw length reading.¿ the returned instrument was examined and the complaint condition was unable to be replicated as the depth gauge functioned as intended and operated smoothly.The compliant is unconfirmed.As no product faults were found with the returned implant, no further investigation is required.A review of the device history records showed there were no issues during the manufacture that would contribute to this complaint condition.No root cause was able to be determined as no product faults were found with the returned implant.Device 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.

Manufacturer Narrative

Patient age was originally reported as being between 16-25 years old.Patient age (and age range) are unknown.Device 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

Update: it was confirmed that plate benders were not used during this case.

• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5004624
• MDR Text Key: 23116291
• Report Number: 2530088-2015-10540
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• 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: 4070014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2000
• 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