MAUDE Adverse Event Report: AESCULAP AG ENNOVATE MIS ROD INSERTER SHORT CONSTR.; INSTRUMENTS POSTERIOR STABILIS

Model Number SZ384R

Device Problems Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: we made a visual inspection of the fracture surface of the instrument.Here we found solder residues from brazing.Batch history review: the manufacturing documents have ben checked and found to b according to specification valid during the time of production.There are no further complaints with this error pattern at hand.Conclusion and root cause: the root cause for the problem is most probably usage and/or product related.Rationale: the root cause there for the described problem ("rod is jamming in the inserter") cannot be determined, because the rod connector (the interface between instrument and rod) is not available for analysis.The tear off of the rod connector we consider as a secondary damage, cause by mechanical overload during the attempt to decouple the rod.The solder resides at the shaft are a sure hint, that the joint between the torn off connector and the shaft was stable enough for normally forces during usage.The primary problem is there for the sticking rod in the tip of the instrument.Possible root causes for a sticking rod are: deformed/damaged end of the rod.Deformed/damaged interface of the rod connector.Handling error (wrong insertion of the rod in the connector).Measure/shape deviations (unlikely).No capa necessary.

Event Description

It was reported the instrument did not release the rod intraoperatively.The reporter indicated that surgery went well.In the end, the rod insertion instrument sz384r could not be detached from the rod.After many attempts to lever up and down, right and left, the instrument simply did not come off.After a last levering attempt the surgeon had the instrument in his hand but the front part was still hanging from the rod (broken off).The surgeon's plan was to possibly remove the entire rod, percutaneously impossible to grasp.After about 1 hour, a doctor had the idea to mill away the bone behind the rod to get more space for removing the broken piece, which was still on the inserted rod.Which finally succeeded.Additional information has been requested, however, as of this report has not yet been received.

• Brand Name: ENNOVATE MIS ROD INSERTER SHORT CONSTR.
• Type of Device: INSTRUMENTS POSTERIOR STABILIS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; am aesculap-platz; tuttlingen, baden-wurttemberg 78501 ; GM 78501
• MDR Report Key: 8772218
• MDR Text Key: 152112341
• Report Number: 9610612-2019-00442
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SZ384R
• Device Catalogue Number: SZ384R
• Device Lot Number: 52460080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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 Outcome(s): Required Intervention