MAUDE Adverse Event Report: SYNTHES MONUMENT AWL WITH PALM HANDLE

Catalog Number 388.656

Device Problem Break (1069)

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

Event Date 08/12/2016

Event Type  malfunction  

Manufacturer Narrative

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.(b)(6).Part 386.656, synthes lot 5329076, supplier lot 568945h06: release to warehouse date: september 08, 2006.Supplier: (b)(4).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 this product that would contribute to this complaint condition.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during surgery the top metal part of the matrix awl has broken off; all broken pieces were removed.The surgery was not prolonged; the procedure was successfully completed and there was no patient harm.Patient outcome was reported as expected.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device (awl with palm handle, part number 388.656, lot number 5329076).The subject device was returned with the complaint condition stating that during surgery, the top metal part of the matrix awl broke off.All broken pieces were removed and the surgery was no prolonged.The surgery was successfully completed with no patient harm.The visual inspection of the returned awl confirmed that the top metal part is broken off as complained.The head of the broken part shows some evidence of hammer blows.There are also scratches at the surface of the whole device.The tip of the instrument is worn and in used condition.As previously reported, the device history record revealed that the subject device was manufactured in september 2006.There were no issues during the manufacturing of the product that would contribute to this complaint condition and no abnormal findings were identified.No product fault could be detected.The complaint condition is confirmed.The root cause is attributed to the age (over ten years) and the worn condition of the subject device.The device was worn from normal use and servicing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AWL WITH PALM HANDLE
• Type of Device: AWL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5910214
• MDR Text Key: 53373404
• Report Number: 1719045-2016-10645
• Device Sequence Number: 1
• Product Code: HWJ
• 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,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2016

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: 388.656
• Device Lot Number: 5329076
• Other Device ID Number: (01)07611819766785(10)5329076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/19/2016; 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2006
• 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: 64 YR