MAUDE Adverse Event Report: SYNTHES MONUMENT ORACLE SLAP HAMMER; HAMMER, SURGICAL

Catalog Number 03.809.972

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product or any subcomponents that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.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 during a transforaminal lumbar interbody fusion (tlif) on (b)(6) 2016, the tip of a rasp broke off during use on the patient but was able to be retrieved.It was confirmed via an x-ray that no part(s) was/ were left in patient.Also during the procedure, the bottom handle of a slap hammer popped off.There is no surgical delay and no harm to patient.The surgeon was able to use other devices to complete the surgery without further issues.The patient's postoperative status was reportedly stable.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Added device code for broken device.Product investigation summary: the returned instruments were examined and the complaint conditions were able to be confirmed in each instance.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.A device history review was performed for the returned instruments¿ lot numbers with no relevant material record reports, non-conformance reports, or complaint-related issues identified.The returned oracle slap hammer instrument was examined and the complaint condition was able to be confirmed as the device¿s shaft was found to be broken, flush with the adapter.The relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision): top-level, adapter, and shaft.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.No definitive root cause was able to be determined; however, the failure mode is typically associated with rough use.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint conditions.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.

• Brand Name: ORACLE SLAP HAMMER
• Type of Device: HAMMER, SURGICAL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5674138
• MDR Text Key: 45747642
• Report Number: 1719045-2016-10431
• Device Sequence Number: 1
• Product Code: FZY
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.809.972
• Device Lot Number: 6417551
• Other Device ID Number: (01)10705034726908(10)6417551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2010
• 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: 65 YR