MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 9MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.004.343S
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Date of event: unknown.Due to intra-operative issues, the device was not implanted/explanted.Part 04.004.343, lot l744122: manufacturing site: (b)(6).Release to warehouse date: january 26, 2018.The device history record shows this lot of devices was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was completed: visual inspection observed significant deformation in the form of shearing at one of its grooved regions at proximal end of the nail.However, the sheared region appears to be only cracked and is still intact with the device.Therefore, no breakage except for shearing was identified.No new issues were identified on other portions of the device except for minor signs of wear that does not affect the product functionality.Functional inspection and complaint replication was not able to be performed due to the as received damaged condition of the device.Furthermore, the mating devices were not returned.However, with the damage observed on the device, the given device complaint condition is consistent with the complaint description and the complaint condition was confirmed.Based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.Dimensional inspection was not able to be performed on the returned device due to significant post manufacture damage.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A definitive root cause for the given complaint condition could not be determined from the provided information.However, it is likely that any unintended excessive off-axis forces encountered by the device during usage as explained in the complaint description such as allowing a wide range of movement and altering the insertion process could have contributed given complaint condition.The overall complaint condition is confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a diaphyseal fracture left tibia procedure on an unknown date, the upper part of a 9mm titanium cannulated tibial nail which was anchored to the insertion handle, ceded and was deformed during insertion of the nail, allowing a wide range of movement and altering the insertion process.It was unknown if another nail was used during the procedure.The procedure was completed successfully by using the same insertion handle.There was no surgical delay.Patient outcome is good.Concomitant device reported: insertion handle (part unknown, lot unknown, quantity unknown) this is report 1 of 1 for (b)(4).

• Brand Name: 9MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7780822
• Report Number: 8030965-2018-55702
• Device Sequence Number: 13706075
• Product Code: JDS
• UDI-Device Identifier: 10886982083890
• UDI-Public: (01)10886982083890
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2018

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
• Operator of Device: Health Professional
• Device Model Number: 04.004.343S
• Device Catalogue Number: 04.004.343S
• Device Lot Number: L744122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/14/2018
• Patient Sequence Number: 1