MAUDE Adverse Event Report: SYNTHES HAGENDORF APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Catalog Number 03.501.080

Device Problems Bent (1059); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device has been received and is currently in the evaluation process.A service history record review has been requested.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 routine inspection and maintenance, while oiling the application instrument for sternal zipfix, it was discovered that the lever is jammed/bent making it difficult to pull the trigger.There was no surgical or patient involvement associated with the reported issue.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A service and repair evaluation was performed for the subject device.The customer reported the lever was jammed and bent, which made it difficult to pull the trigger.The repair technician reported that ¿bent¿ is the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit on (b)(4) 2015 for additional evaluation.The service and repair evaluation was confirmed.A product development evaluation was performed at the synthes chu for the subject device.One application instrument for sternal zipfix (part number 03.501.080, lot number 8725319) was received with the complaint that the lever is jammed/bent and that this makes it difficult to pull the trigger.The complaint condition is confirmed as the trigger cannot be operated smoothly due to the bending of the spring stop components.The specific circumstances that resulted in bending are unknown.Thus, the root cause could not be definitively determined.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The related product drawings were reviewed and no product design issues or discrepancies were observed that may have contributed to the complaint condition.As the complaint conditions were each discovered during routine inspection the specific circumstances that resulted in issues are unknown.Thus, the root cause could not be definitively determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A service & repair history review: part 03.501.080, lot no: 8725319.No service history review can be performed as this is a lot controlled item.The manufacture date of this item is 3-dec-2013.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.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 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: APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CO CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CO CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5064855
• MDR Text Key: 25299293
• Report Number: 1719045-2015-10588
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8725319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2013
• 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